A PHP Error was encountered

Severity: Notice

Message: Undefined index: pmaNumber

Filename: fda.report/pmn_item.php

Line Number: 21

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 21
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 25

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 25
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 25

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 25
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 26

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 26
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 26

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 26
Function: _error_handler

510(k) FDA Premarket Notification K232144

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 33

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 33
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: classificationName

Filename: fda.report/pmn_item.php

Line Number: 34

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 34
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 35

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 35
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 54

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 54
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 55

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 55
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 66

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 66
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 66

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 66
Function: _error_handler

The following data is part of a premarket notification filed by with the FDA for .

Pre-market Notification Details

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceId

Filename: fda.report/pmn_item.php

Line Number: 78

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 78
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: 501kNumber

Filename: fda.report/pmn_item.php

Line Number: 79

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 79
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 80

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 80
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: classificationName

Filename: fda.report/pmn_item.php

Line Number: 81

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 81
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicantFull

Filename: fda.report/pmn_item.php

Line Number: 82

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 82
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicantContact

Filename: fda.report/pmn_item.php

Line Number: 83

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 83
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicantContact

Filename: fda.report/pmn_item.php

Line Number: 83

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 83
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondent

Filename: fda.report/pmn_item.php

Line Number: 84

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 84
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondentContact

Filename: fda.report/pmn_item.php

Line Number: 84

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 84
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondentContact

Filename: fda.report/pmn_item.php

Line Number: 85

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 85
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondent

Filename: fda.report/pmn_item.php

Line Number: 85

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 85
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: classificationPC

Filename: fda.report/pmn_item.php

Line Number: 87

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 87
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: subsequentPC

Filename: fda.report/pmn_item.php

Line Number: 90

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 90
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: regulationNumber

Filename: fda.report/pmn_item.php

Line Number: 95

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 95
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: decision

Filename: fda.report/pmn_item.php

Line Number: 99

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 99
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: regulationMS

Filename: fda.report/pmn_item.php

Line Number: 100

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 100
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: 501kReviewPanel

Filename: fda.report/pmn_item.php

Line Number: 103

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 103
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: fdaReview

Filename: fda.report/pmn_item.php

Line Number: 106

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 106
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: fdaReview

Filename: fda.report/pmn_item.php

Line Number: 107

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 107
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: type

Filename: fda.report/pmn_item.php

Line Number: 109

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 109
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: thirdPartyReviewed

Filename: fda.report/pmn_item.php

Line Number: 110

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 110
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: combinationProduct

Filename: fda.report/pmn_item.php

Line Number: 111

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 111
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: dateReceived

Filename: fda.report/pmn_item.php

Line Number: 112

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 112
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: decisionDate

Filename: fda.report/pmn_item.php

Line Number: 113

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 113
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: summary

Filename: fda.report/pmn_item.php

Line Number: 114

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 114
Function: _error_handler

Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630037879732 K232144 000
07630037880318 K232144 000
07630037880301 K232144 000
07630037880295 K232144 000
07630037880288 K232144 000
07630037880271 K232144 000
07630037880264 K232144 000
07630037880257 K232144 000
07630037880240 K232144 000
07630037880325 K232144 000
07630037880332 K232144 000
07630037880523 K232144 000
07630037880516 K232144 000
07630037880509 K232144 000
07630037880387 K232144 000
07630037880370 K232144 000
07630037880363 K232144 000
07630037880356 K232144 000
07630037880349 K232144 000
07630037880233 K232144 000
07630037880226 K232144 000
07630037879978 K232144 000
07630037879947 K232144 000
07630037879916 K232144 000
07630037879886 K232144 000
07630037879855 K232144 000
07630037879824 K232144 000
07630037879794 K232144 000
07630037879763 K232144 000
07630037880004 K232144 000
07630037880035 K232144 000
07630037880219 K232144 000
07630037880202 K232144 000
07630037880196 K232144 000
07630037880189 K232144 000
07630037880158 K232144 000
07630037880127 K232144 000
07630037880097 K232144 000
07630037880066 K232144 000
07630037880530 K232144 000
07630037880547 K232144 000
07630037881292 K232144 000
07630037881261 K232144 000
07630037881230 K232144 000
07630037881209 K232144 000
07630037881179 K232144 000
07630037881148 K232144 000
07630037881117 K232144 000
07630037881087 K232144 000
07630037881322 K232144 000
07630037881353 K232144 000
07630037881643 K232144 000
07630037881605 K232144 000
07630037881568 K232144 000
07630037881520 K232144 000
07630037881490 K232144 000
07630037881469 K232144 000
07630037881414 K232144 000
07630037881384 K232144 000
07630037881056 K232144 000
07630037881025 K232144 000
07630037880691 K232144 000
07630037880615 K232144 000
07630037880608 K232144 000
07630037880592 K232144 000
07630037880585 K232144 000
07630037880578 K232144 000
07630037880561 K232144 000
07630037880554 K232144 000
07630037880721 K232144 000
07630037880752 K232144 000
07630037880998 K232144 000
07630037880967 K232144 000
07630037880936 K232144 000
07630037880905 K232144 000
07630037880875 K232144 000
07630037880844 K232144 000
07630037880813 K232144 000
07630037880783 K232144 000
07630037881674 K232144 000
07630037862635 K232144 000
07630037863274 K232144 000
07630037863236 K232144 000
07630037863212 K232144 000
07630037863199 K232144 000
07630037863175 K232144 000
07630037863151 K232144 000
07630037863120 K232144 000
07630037863090 K232144 000
07630037863298 K232144 000
07630037863311 K232144 000
07630037863564 K232144 000
07630037863540 K232144 000
07630037863502 K232144 000
07630037863489 K232144 000
07630037863465 K232144 000
07630037863427 K232144 000
07630037863359 K232144 000
07630037863335 K232144 000
07630037863076 K232144 000
07630037863052 K232144 000
07630037862819 K232144 000
07630037862796 K232144 000
07630037862772 K232144 000
07630037862734 K232144 000
07630037862710 K232144 000
07630037862697 K232144 000
07630037862673 K232144 000
07630037862659 K232144 000
07630037862833 K232144 000
07630037862857 K232144 000
07630037863038 K232144 000
07630037863014 K232144 000
07630037862994 K232144 000
07630037862956 K232144 000
07630037862932 K232144 000
07630037862918 K232144 000
07630037862901 K232144 000
07630037862871 K232144 000
07630037863595 K232144 000
07630037863625 K232144 000
07630037879343 K232144 000
07630037879312 K232144 000
07630037879282 K232144 000
07630037879251 K232144 000
07630037879220 K232144 000
07630037879190 K232144 000
07630037879169 K232144 000
07630037879138 K232144 000
07630037879374 K232144 000
07630037879404 K232144 000
07630037879671 K232144 000
07630037879640 K232144 000
07630037879589 K232144 000
07630037879558 K232144 000
07630037879527 K232144 000
07630037879497 K232144 000
07630037879466 K232144 000
07630037879435 K232144 000
07630037879107 K232144 000
07630037879077 K232144 000
07630037878742 K232144 000
07630037878711 K232144 000
07630037878681 K232144 000
07630037878650 K232144 000
07630037878629 K232144 000
07630037878599 K232144 000
07630037878568 K232144 000
07630037863649 K232144 000
07630037878773 K232144 000
07630037878803 K232144 000
07630037879046 K232144 000
07630037879015 K232144 000
07630037878988 K232144 000
07630037878957 K232144 000
07630037878926 K232144 000
07630037878896 K232144 000
07630037878865 K232144 000
07630037878834 K232144 000
07630037879701 K232144 000
07630037881704 K232144 000
07630037890034 K232144 000
07630037890324 K232144 000
07630037890317 K232144 000
07630037890300 K232144 000
07630037890294 K232144 000
07630037890287 K232144 000
07630037890270 K232144 000
07630037890263 K232144 000
07630037890256 K232144 000
07630037890331 K232144 000
07630037890348 K232144 000
07630037890454 K232144 000
07630037890416 K232144 000
07630037890409 K232144 000
07630037890393 K232144 000
07630037890386 K232144 000
07630037890379 K232144 000
07630037890362 K232144 000
07630037890355 K232144 000
07630037890249 K232144 000
07630037890232 K232144 000
07630037890126 K232144 000
07630037890119 K232144 000
07630037890102 K232144 000
07630037890096 K232144 000
07630037890089 K232144 000
07630037890072 K232144 000
07630037890065 K232144 000
07630037890041 K232144 000
07630037890133 K232144 000
07630037890140 K232144 000
07630037890225 K232144 000
07630037890218 K232144 000
07630037890201 K232144 000
07630037890195 K232144 000
07630037890188 K232144 000
07630037890171 K232144 000
07630037890164 K232144 000
07630037890157 K232144 000
07630037890461 K232144 000
07630037890478 K232144 000
07630037890805 K232144 000
07630037890782 K232144 000
07630037890775 K232144 000
07630037890768 K232144 000
07630037890751 K232144 000
07630037890744 K232144 000
07630037890737 K232144 000
07630037890706 K232144 000
07630037890812 K232144 000
07630037890829 K232144 000
07630037890904 K232144 000
07630037890898 K232144 000
07630037890881 K232144 000
07630037890874 K232144 000
07630037890867 K232144 000
07630037890850 K232144 000
07630037890843 K232144 000
07630037890836 K232144 000
07630037890690 K232144 000
07630037890683 K232144 000
07630037890553 K232144 000
07630037890546 K232144 000
07630037890539 K232144 000
07630037890522 K232144 000
07630037890515 K232144 000
07630037890508 K232144 000
07630037890492 K232144 000
07630037890485 K232144 000
07630037890560 K232144 000
07630037890577 K232144 000
07630037890676 K232144 000
07630037890645 K232144 000
07630037890638 K232144 000
07630037890621 K232144 000
07630037890614 K232144 000
07630037890607 K232144 000
07630037890591 K232144 000
07630037890584 K232144 000
07630037890911 K232144 000
07630037881735 K232144 000
07630037889403 K232144 000
07630037882534 K232144 000
07630037882510 K232144 000
07630037882480 K232144 000
07630037882459 K232144 000
07630037882428 K232144 000
07630037882398 K232144 000
07630037882367 K232144 000
07630037889410 K232144 000
07630037889427 K232144 000
07630037889519 K232144 000
07630037889502 K232144 000
07630037889496 K232144 000
07630037889489 K232144 000
07630037889472 K232144 000
07630037889465 K232144 000
07630037889458 K232144 000
07630037889434 K232144 000
07630037882336 K232144 000
07630037882305 K232144 000
07630037881971 K232144 000
07630037881940 K232144 000
07630037881919 K232144 000
07630037881889 K232144 000
07630037881858 K232144 000
07630037881827 K232144 000
07630037881797 K232144 000
07630037881766 K232144 000
07630037882008 K232144 000
07630037882039 K232144 000
07630037882275 K232144 000
07630037882244 K232144 000
07630037882213 K232144 000
07630037882183 K232144 000
07630037882152 K232144 000
07630037882121 K232144 000
07630037882091 K232144 000
07630037882060 K232144 000
07630037889533 K232144 000
07630037889540 K232144 000
07630037889847 K232144 000
07630037889830 K232144 000
07630037889809 K232144 000
07630037889793 K232144 000
07630037889786 K232144 000
07630037889779 K232144 000
07630037889762 K232144 000
07630037889755 K232144 000
07630037889854 K232144 000
07630037889861 K232144 000
07630037889977 K232144 000
07630037889939 K232144 000
07630037889922 K232144 000
07630037889915 K232144 000
07630037889908 K232144 000
07630037889892 K232144 000
07630037889885 K232144 000
07630037889878 K232144 000
07630037889748 K232144 000
07630037889731 K232144 000
07630037889625 K232144 000
07630037889618 K232144 000
07630037889601 K232144 000
07630037889595 K232144 000
07630037889588 K232144 000
07630037889571 K232144 000
07630037889564 K232144 000
07630037889557 K232144 000
07630037889632 K232144 000
07630037889649 K232144 000
07630037889724 K232144 000
07630037889717 K232144 000
07630037889700 K232144 000
07630037889694 K232144 000
07630037889687 K232144 000
07630037889670 K232144 000
07630037889663 K232144 000
07630037889656 K232144 000
07630037890027 K232144 000

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 156
Function: _error_handler


© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.