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 K212450

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
B084AC2121412070 K212450 000
B084AC1121411000 K212450 000
B084AC1121410070 K212450 000
B084AC1121410040 K212450 000
B084AC1121410000 K212450 000
B084AC1121409070 K212450 000
B084AC1121409040 K212450 000
B084AC1121409000 K212450 000
B084AC1121408070 K212450 000
B084AC1121408040 K212450 000
B084AC1121408000 K212450 000
B084AC1121411040 K212450 000
B084AC1121411070 K212450 000
B084AC2121411070 K212450 000
B084AC2121410070 K212450 000
B084AC2121409070 K212450 000
B084AC2121408070 K212450 000
B084AC2121407070 K212450 000
B084AC2121406070 K212450 000
B084AC2121405070 K212450 000
B084AC1121412070 K212450 000
B084AC1121412040 K212450 000
B084AC1121412000 K212450 000
B084AC1121407070 K212450 000
B084AC1121407040 K212450 000
B084AC1141610000 K212450 000
B084AC1141609040 K212450 000
B084AC1141609000 K212450 000
B084AC1141608040 K212450 000
B084AC1141608000 K212450 000
B084AC1141607040 K212450 000
B084AC1141607000 K212450 000
B084AC1141606040 K212450 000
B084AC1141606000 K212450 000
B084AC1141605040 K212450 000
B084AC1141610040 K212450 000
B084AC1141611000 K212450 000
B084AC1121407000 K212450 000
B084AC1121406070 K212450 000
B084AC1121406040 K212450 000
B084AC1121406000 K212450 000
B084AC1121405070 K212450 000
B084AC1121405040 K212450 000
B084AC1121405000 K212450 000
B084AC1141612040 K212450 000
B084AC1141612000 K212450 000
B084AC1141611040 K212450 000
B084AC1141605000 K212450 000
B084AC1111312070 K212450 000
B084AC1111308040 K212450 000
B084AC1111308000 K212450 000
B084AC1111307070 K212450 000
B084AC1111307040 K212450 000
B084AC1111307000 K212450 000
B084AC1111306070 K212450 000
B084AC1111306040 K212450 000
B084AC1111306000 K212450 000
B084AC1111305070 K212450 000
B084AC1111305040 K212450 000
B084AC1111308070 K212450 000
B084AC1111309000 K212450 000
B084AC1111312040 K212450 000
B084AC1111312000 K212450 000
B084AC1111311070 K212450 000
B084AC1111311040 K212450 000
B084AC1111311000 K212450 000
B084AC1111310070 K212450 000
B084AC1111310040 K212450 000
B084AC1111310000 K212450 000
B084AC1111309070 K212450 000
B084AC1111309040 K212450 000
B084AC1111305000 K212450 000
B084AC4141612070 K212450 000
B084AC4121407070 K212450 000
B084AC4121406070 K212450 000
B084AC4121405070 K212450 000
B084AC2141612070 K212450 000
B084AC2141611070 K212450 000
B084AC2141610070 K212450 000
B084AC2141609070 K212450 000
B084AC2141608070 K212450 000
B084AC2141607070 K212450 000
B084AC2141606070 K212450 000
B084AC4121408070 K212450 000
B084AC4121409070 K212450 000
B084AC4141611070 K212450 000
B084AC4141610070 K212450 000
B084AC4141609070 K212450 000
B084AC4141608070 K212450 000
B084AC4141607070 K212450 000
B084AC4141606070 K212450 000
B084AC4141605070 K212450 000
B084AC4121412070 K212450 000
B084AC4121411070 K212450 000
B084AC4121410070 K212450 000
B084AC2141605070 K212450 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


© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.