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 K222380

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
09348215096878 K222380 000
09348215097004 K222380 000
09348215097011 K222380 000
09348215097516 K222380 000
09348215097523 K222380 000
09348215097547 K222380 000
09348215097646 K222380 000
09348215097653 K222380 000
09348215097660 K222380 000
09348215097677 K222380 000
09348215097684 K222380 000
09348215096991 K222380 000
09348215096984 K222380 000
09348215096885 K222380 000
09348215096892 K222380 000
09348215096908 K222380 000
09348215096915 K222380 000
09348215096922 K222380 000
09348215096939 K222380 000
09348215096946 K222380 000
09348215096953 K222380 000
09348215096960 K222380 000
09348215096977 K222380 000
09348215097691 K222380 000
09348215097707 K222380 000
09348215098247 K222380 000
09348215098254 K222380 000
09348215098476 K222380 000
09348215098483 K222380 000
09348215098490 K222380 000
09348215098506 K222380 000
09348215098513 K222380 000
09348215098520 K222380 000
09348215098537 K222380 000
09348215098544 K222380 000
09348215097820 K222380 000
09348215097813 K222380 000
09348215097714 K222380 000
09348215097721 K222380 000
09348215097738 K222380 000
09348215097745 K222380 000
09348215097752 K222380 000
09348215097769 K222380 000
09348215097776 K222380 000
09348215097783 K222380 000
09348215097790 K222380 000
09348215097806 K222380 000
09348215098551 K222380 000
09348215096861 K222380 000
09348215129538 K222380 000
09348215109714 K222380 000
09348215109721 K222380 000
09348215109738 K222380 000
09348215110178 K222380 000
09348215110185 K222380 000
09348215110192 K222380 000
09348215096571 K222380 000
09348215096588 K222380 000
09348215096595 K222380 000
09348215096601 K222380 000
09348215109707 K222380 000
09348215109691 K222380 000
09348215097493 K222380 000
09348215097608 K222380 000
09348215097615 K222380 000
09348215097622 K222380 000
09348215097639 K222380 000
09348215098223 K222380 000
09348215098346 K222380 000
09348215108922 K222380 000
09348215108939 K222380 000
09348215108946 K222380 000
09348215096618 K222380 000
09348215096625 K222380 000
09348215096755 K222380 000
09348215096762 K222380 000
09348215096779 K222380 000
09348215096786 K222380 000
09348215096793 K222380 000
09348215096809 K222380 000
09348215096816 K222380 000
09348215096823 K222380 000
09348215096830 K222380 000
09348215096847 K222380 000
09348215096748 K222380 000
09348215096731 K222380 000
09348215096632 K222380 000
09348215096649 K222380 000
09348215096656 K222380 000
09348215096663 K222380 000
09348215096670 K222380 000
09348215096687 K222380 000
09348215096694 K222380 000
09348215096700 K222380 000
09348215096717 K222380 000
09348215096724 K222380 000
09348215096854 K222380 000
09348215098568 K222380 000
09348215109899 K222380 000
09348215113841 K222380 000
09348215113858 K222380 000
09348215113865 K222380 000
09348215113872 K222380 000
09348215113889 K222380 000
09348215113896 K222380 000
09348215113902 K222380 000
09348215113919 K222380 000
09348215113926 K222380 000
09348215113933 K222380 000
09348215110017 K222380 000
09348215110000 K222380 000
09348215109905 K222380 000
09348215109912 K222380 000
09348215109929 K222380 000
09348215109936 K222380 000
09348215109943 K222380 000
09348215109950 K222380 000
09348215109967 K222380 000
09348215109974 K222380 000
09348215109981 K222380 000
09348215109998 K222380 000
09348215113940 K222380 000
09348215113957 K222380 000
09348215097929 K222380 000
09348215098377 K222380 000
09348215098384 K222380 000
09348215098391 K222380 000
09348215098407 K222380 000
09348215098414 K222380 000
09348215098421 K222380 000
09348215098438 K222380 000
09348215098445 K222380 000
09348215098452 K222380 000
09348215097912 K222380 000
09348215097905 K222380 000
09348215113964 K222380 000
09348215113971 K222380 000
09348215113988 K222380 000
09348215097837 K222380 000
09348215097844 K222380 000
09348215097851 K222380 000
09348215097868 K222380 000
09348215097875 K222380 000
09348215097882 K222380 000
09348215097899 K222380 000
09348215098469 K222380 000
09348215109882 K222380 000
09348215098575 K222380 000
09348215099886 K222380 000
09348215099893 K222380 000
09348215099909 K222380 000
09348215099916 K222380 000
09348215099923 K222380 000
09348215099930 K222380 000
09348215099947 K222380 000
09348215099954 K222380 000
09348215099961 K222380 000
09348215099978 K222380 000
09348215099879 K222380 000
09348215099862 K222380 000
09348215098582 K222380 000
09348215098599 K222380 000
09348215098605 K222380 000
09348215098612 K222380 000
09348215098629 K222380 000
09348215098636 K222380 000
09348215098643 K222380 000
09348215098650 K222380 000
09348215099848 K222380 000
09348215099855 K222380 000
09348215099985 K222380 000
09348215099992 K222380 000
09348215109646 K222380 000
09348215109653 K222380 000
09348215109660 K222380 000
09348215109677 K222380 000
09348215109684 K222380 000
09348215109820 K222380 000
09348215109837 K222380 000
09348215109844 K222380 000
09348215109851 K222380 000
09348215109868 K222380 000
09348215109639 K222380 000
09348215109622 K222380 000
09348215100001 K222380 000
09348215100018 K222380 000
09348215100025 K222380 000
09348215100032 K222380 000
09348215100049 K222380 000
09348215100056 K222380 000
09348215100063 K222380 000
09348215100070 K222380 000
09348215100087 K222380 000
09348215108762 K222380 000
09348215109875 K222380 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.