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 K240837

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
07290117803134 K240837 000
07290117801765 K240837 000
07290117801772 K240837 000
07290117801789 K240837 000
07290117801796 K240837 000
07290117801802 K240837 000
07290117801826 K240837 000
07290117801833 K240837 000
07290117801840 K240837 000
07290117801871 K240837 000
07290117801888 K240837 000
07290117801895 K240837 000
07290117801918 K240837 000
07290117801758 K240837 000
07290117803264 K240837 000
07290117803141 K240837 000
07290117803158 K240837 000
07290117803165 K240837 000
07290117803172 K240837 000
07290117803189 K240837 000
07290117803196 K240837 000
07290117803202 K240837 000
07290117803219 K240837 000
07290117803226 K240837 000
07290117803233 K240837 000
07290117803240 K240837 000
07290117803257 K240837 000
07290117801925 K240837 000
07290117801932 K240837 000
07290117801949 K240837 000
07290117802298 K240837 000
07290117802304 K240837 000
07290117802311 K240837 000
07290117802328 K240837 000
07290117802335 K240837 000
07290117802342 K240837 000
07290117802359 K240837 000
07290117802366 K240837 000
07290117802373 K240837 000
07290117802380 K240837 000
07290117802397 K240837 000
07290117802403 K240837 000
07290117802281 K240837 000
07290117802267 K240837 000
07290117801956 K240837 000
07290117801987 K240837 000
07290117801994 K240837 000
07290117802007 K240837 000
07290117802038 K240837 000
07290117802045 K240837 000
07290117802052 K240837 000
07290117802212 K240837 000
07290117802229 K240837 000
07290117802236 K240837 000
07290117802243 K240837 000
07290117802250 K240837 000
07290117802410 K240837 000
07290117802915 K240837 000
07290117802632 K240837 000
07290117802649 K240837 000
07290117802656 K240837 000
07290117802663 K240837 000
07290117802670 K240837 000
07290117802687 K240837 000
07290117802694 K240837 000
07290117802700 K240837 000
07290117802717 K240837 000
07290117802724 K240837 000
07290117802731 K240837 000
07290117802748 K240837 000
07290117802625 K240837 000
07290117802618 K240837 000
07290117802922 K240837 000
07290117802939 K240837 000
07290117802946 K240837 000
07290117802526 K240837 000
07290117802533 K240837 000
07290117802540 K240837 000
07290117802557 K240837 000
07290117802564 K240837 000
07290117802571 K240837 000
07290117802588 K240837 000
07290117802595 K240837 000
07290117802601 K240837 000
07290117802755 K240837 000
07290117802762 K240837 000
07290117802779 K240837 000
07290117803004 K240837 000
07290117803011 K240837 000
07290117803028 K240837 000
07290117803035 K240837 000
07290117803042 K240837 000
07290117803059 K240837 000
07290117803066 K240837 000
07290117803073 K240837 000
07290117803080 K240837 000
07290117803097 K240837 000
07290117803103 K240837 000
07290117803110 K240837 000
07290117802991 K240837 000
07290117802984 K240837 000
07290117802786 K240837 000
07290117802793 K240837 000
07290117802823 K240837 000
07290117802830 K240837 000
07290117802847 K240837 000
07290117802854 K240837 000
07290117802885 K240837 000
07290117802892 K240837 000
07290117802908 K240837 000
07290117802953 K240837 000
07290117802960 K240837 000
07290117802977 K240837 000
07290117803127 K240837 000
07290117802427 K240837 000
07290117801673 K240837 000
07290117800522 K240837 000
07290117800539 K240837 000
07290117800546 K240837 000
07290117800058 K240837 000
07290117800065 K240837 000
07290117800072 K240837 000
07290117800089 K240837 000
07290117800096 K240837 000
07290117800119 K240837 000
07290117800126 K240837 000
07290117800133 K240837 000
07290117800140 K240837 000
07290117800515 K240837 000
07290117800508 K240837 000
07290117801680 K240837 000
07290117801697 K240837 000
07290117801703 K240837 000
07290117801710 K240837 000
07290117801727 K240837 000
07290117801734 K240837 000
07290117801741 K240837 000
07290117800454 K240837 000
07290117800461 K240837 000
07290117800478 K240837 000
07290117800485 K240837 000
07290117800492 K240837 000
07290117800157 K240837 000
07290117800171 K240837 000
07290117800188 K240837 000
07290117800362 K240837 000
07290117800379 K240837 000
07290117800386 K240837 000
07290117800409 K240837 000
07290117800416 K240837 000
07290117800423 K240837 000
07290117800430 K240837 000
07290117800447 K240837 000
07290117800003 K240837 000
07290117800010 K240837 000
07290117800027 K240837 000
07290117800034 K240837 000
07290117800355 K240837 000
07290117800348 K240837 000
07290117800195 K240837 000
07290117800201 K240837 000
07290117800218 K240837 000
07290117800232 K240837 000
07290117800249 K240837 000
07290117800256 K240837 000
07290117800263 K240837 000
07290117800287 K240837 000
07290117800294 K240837 000
07290117800300 K240837 000
07290117800317 K240837 000
07290117800324 K240837 000
07290117800041 K240837 000
07290117802434 K240837 000
07290117800621 K240837 000
07290117800638 K240837 000
07290117800645 K240837 000
07290117800669 K240837 000
07290117800676 K240837 000
07290117800683 K240837 000
07290117800690 K240837 000
07290117800706 K240837 000
07290117800713 K240837 000
07290117800720 K240837 000
07290117800737 K240837 000
07290117800744 K240837 000
07290117800614 K240837 000
07290117800591 K240837 000
07290117802441 K240837 000
07290117802458 K240837 000
07290117802465 K240837 000
07290117802472 K240837 000
07290117802489 K240837 000
07290117802496 K240837 000
07290117802502 K240837 000
07290117802519 K240837 000
07290117800553 K240837 000
07290117800560 K240837 000
07290117800577 K240837 000
07290117800584 K240837 000
07290117800751 K240837 000
07290117800768 K240837 000
07290117800775 K240837 000
07290117801543 K240837 000
07290117801550 K240837 000
07290117801567 K240837 000
07290117801574 K240837 000
07290117801581 K240837 000
07290117801598 K240837 000
07290117801604 K240837 000
07290117801611 K240837 000
07290117801628 K240837 000
07290117801635 K240837 000
07290117801642 K240837 000
07290117801659 K240837 000
07290117801536 K240837 000
07290117801529 K240837 000
07290117801253 K240837 000
07290117801260 K240837 000
07290117801420 K240837 000
07290117801437 K240837 000
07290117801444 K240837 000
07290117801451 K240837 000
07290117801468 K240837 000
07290117801475 K240837 000
07290117801482 K240837 000
07290117801499 K240837 000
07290117801505 K240837 000
07290117801512 K240837 000
07290117801666 K240837 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.