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 K231899

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
M71165121410081 K231899 000
M71165161906081 K231899 000
M71165161811121 K231899 000
M71165161811081 K231899 000
M71165161810121 K231899 000
M71165161810081 K231899 000
M71165161809121 K231899 000
M71165161809081 K231899 000
M71165161808121 K231899 000
M71165161808081 K231899 000
M71165161807121 K231899 000
M71165161807081 K231899 000
M71165161806121 K231899 000
M71165161912121 K231899 000
M71165161912081 K231899 000
M71165161911121 K231899 000
M71165161911081 K231899 000
M71165161910121 K231899 000
M71165161907081 K231899 000
M71165151711081 K231899 000
M71165121409121 K231899 000
M71165121409081 K231899 000
M71165121408121 K231899 000
M71165121408081 K231899 000
M71165121407121 K231899 000
M71165121407081 K231899 000
M71165121406121 K231899 000
M71165121406081 K231899 000
M71165121405121 K231899 000
M71165121405081 K231899 000
M711LS758020 K231899 000
M711LS758010 K231899 000
M71165161806081 K231899 000
M71165161805081 K231899 000
M71165151712121 K231899 000
M71165151712081 K231899 000
M71165151711121 K231899 000
M71165161910081 K231899 000
M71165161909121 K231899 000
M71165161909081 K231899 000
M71165161812081 K231899 000
M711LS759050 K231899 000
M711LS759040 K231899 000
M711LS759030 K231899 000
M711LS759020 K231899 000
M711LS759010 K231899 000
M711LS758270 K231899 000
M711LS758260 K231899 000
M711LS758250 K231899 000
M711LS758240 K231899 000
M711LS758230 K231899 000
M711LS758220 K231899 000
M711LS758200 K231899 000
M711LS758190 K231899 000
M711LS758180 K231899 000
M711LS758120 K231899 000
M711LS758110 K231899 000
M711LS758040 K231899 000
M711LS758050 K231899 000
M71165161908121 K231899 000
M71165161908081 K231899 000
M71165161907121 K231899 000
M71165161906121 K231899 000
M71165161905081 K231899 000
M71165161812121 K231899 000
M711LS758210 K231899 000
M711LS758170 K231899 000
M711LS758160 K231899 000
M711LS758150 K231899 000
M711LS758140 K231899 000
M711LS758130 K231899 000
M711LS758100 K231899 000
M711LS758090 K231899 000
M711LS758080 K231899 000
M711LS758070 K231899 000
M711LS758060 K231899 000
M711LS758030 K231899 000
M71165121410121 K231899 000
M71165151710121 K231899 000
M71165141708081 K231899 000
M71165141707121 K231899 000
M71165141707081 K231899 000
M71165141706121 K231899 000
M71165141706081 K231899 000
M71165141705081 K231899 000
M71165141612121 K231899 000
M71165141612081 K231899 000
M71165141611121 K231899 000
M71165141611081 K231899 000
M71165141610121 K231899 000
M71165141610081 K231899 000
M71165141609121 K231899 000
M71165141609081 K231899 000
M71165141608121 K231899 000
M71165141608081 K231899 000
M71165141607121 K231899 000
M71165141708121 K231899 000
M71165141709081 K231899 000
M71165151710081 K231899 000
M71165151709121 K231899 000
M71165151709081 K231899 000
M71165151708121 K231899 000
M71165151708081 K231899 000
M71165151707121 K231899 000
M71165151707081 K231899 000
M71165151706121 K231899 000
M71165151706081 K231899 000
M71165151705081 K231899 000
M71165141712121 K231899 000
M71165141712081 K231899 000
M71165141711121 K231899 000
M71165141711081 K231899 000
M71165141710121 K231899 000
M71165141710081 K231899 000
M71165141709121 K231899 000
M71165141607081 K231899 000
M71165141606121 K231899 000
M71165141606081 K231899 000
M71165121511121 K231899 000
M71165121511081 K231899 000
M71165121510121 K231899 000
M71165121510081 K231899 000
M71165121509121 K231899 000
M71165121509081 K231899 000
M71165121508121 K231899 000
M71165121508081 K231899 000
M71165121507121 K231899 000
M71165121507081 K231899 000
M71165121506121 K231899 000
M71165121506081 K231899 000
M71165121505121 K231899 000
M71165121505081 K231899 000
M71165121412121 K231899 000
M71165121412081 K231899 000
M71165121411121 K231899 000
M71165121512081 K231899 000
M71165121512121 K231899 000
M71165141605081 K231899 000
M71165131512121 K231899 000
M71165131512081 K231899 000
M71165131511121 K231899 000
M71165131511081 K231899 000
M71165131510121 K231899 000
M71165131510081 K231899 000
M71165131509121 K231899 000
M71165131509081 K231899 000
M71165131508121 K231899 000
M71165131508081 K231899 000
M71165131507121 K231899 000
M71165131507081 K231899 000
M71165131506121 K231899 000
M71165131506081 K231899 000
M71165131505121 K231899 000
M71165131505081 K231899 000
M71165121411081 K231899 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.