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 K230844

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
M572TCR023123S011 K230844 000
M572TCR023144S011 K230844 000
M572TCR023145N011 K230844 000
M572TCR023145S011 K230844 000
M572TCR023146N011 K230844 000
M572TCR023146S011 K230844 000
M572TCR023147S011 K230844 000
M572TCR023161S011 K230844 000
M572TCR023162N011 K230844 000
M572TCR023162S011 K230844 000
M572TCR023163N011 K230844 000
M572TCR023144N011 K230844 000
M572TCR023143S011 K230844 000
M572TCR023143N011 K230844 000
M572TCR023124N011 K230844 000
M572TCR023124S011 K230844 000
M572TCR023125N011 K230844 000
M572TCR023125S011 K230844 000
M572TCR023126N011 K230844 000
M572TCR023126S011 K230844 000
M572TCR023127S011 K230844 000
M572TCR023141S011 K230844 000
M572TCR023142N011 K230844 000
M572TCR023142S011 K230844 000
M572TCR023163S011 K230844 000
M572TCR023164N011 K230844 000
M572TCR023185N011 K230844 000
M572TCR023185S011 K230844 000
M572TCR023186N011 K230844 000
M572TCR023186S011 K230844 000
M572TCR023187S011 K230844 000
M572TCR030181S011 K230844 000
M572TCR030182N011 K230844 000
M572TCR030182S011 K230844 000
M572TCR030183N011 K230844 000
M572TCR030183S011 K230844 000
M572TCR023184S011 K230844 000
M572TCR023184N011 K230844 000
M572TCR023183S011 K230844 000
M572TCR023164S011 K230844 000
M572TCR023165N011 K230844 000
M572TCR023165S011 K230844 000
M572TCR023166N011 K230844 000
M572TCR023166S011 K230844 000
M572TCR023167S011 K230844 000
M572TCR023181S011 K230844 000
M572TCR023182N011 K230844 000
M572TCR023182S011 K230844 000
M572TCR023183N011 K230844 000
M572TCR030184N011 K230844 000
M572TCR023123N011 K230844 000
M572TCR023061S011 K230844 000
M572TCR023073N011 K230844 000
M572TCR023073S011 K230844 000
M572TCR023074N011 K230844 000
M572TCR023074S011 K230844 000
M572TCR023075N011 K230844 000
M572TCR023075S011 K230844 000
M572TCR023076N011 K230844 000
M572TCR023076S011 K230844 000
M572TCR023077S011 K230844 000
M572TCR023081S011 K230844 000
M572TCR023072S011 K230844 000
M572TCR023072N011 K230844 000
M572TCR023071S011 K230844 000
M572TCR023062N011 K230844 000
M572TCR023062S011 K230844 000
M572TCR023063N011 K230844 000
M572TCR023063S011 K230844 000
M572TCR023064N011 K230844 000
M572TCR023064S011 K230844 000
M572TCR023065N011 K230844 000
M572TCR023066N011 K230844 000
M572TCR023066S011 K230844 000
M572TCR023067S011 K230844 000
M572TCR023082N011 K230844 000
M572TCR023082S011 K230844 000
M572TCR023103S011 K230844 000
M572TCR023104N011 K230844 000
M572TCR023104S011 K230844 000
M572TCR023105N011 K230844 000
M572TCR023105S011 K230844 000
M572TCR023106N011 K230844 000
M572TCR023106S011 K230844 000
M572TCR023107S011 K230844 000
M572TCR023121S011 K230844 000
M572TCR023122N011 K230844 000
M572TCR023103N011 K230844 000
M572TCR023102S011 K230844 000
M572TCR023102N011 K230844 000
M572TCR023083N011 K230844 000
M572TCR023083S011 K230844 000
M572TCR023084N011 K230844 000
M572TCR023084S011 K230844 000
M572TCR023085N011 K230844 000
M572TCR023085S011 K230844 000
M572TCR023086N011 K230844 000
M572TCR023086S011 K230844 000
M572TCR023087S011 K230844 000
M572TCR023101S011 K230844 000
M572TCR023122S011 K230844 000
M572TCR033106N011 K230844 000
M572TCR033127S011 K230844 000
M572TCR033141S011 K230844 000
M572TCR033142N011 K230844 000
M572TCR033142S011 K230844 000
M572TCR033143N011 K230844 000
M572TCR033143S011 K230844 000
M572TCR033144N011 K230844 000
M572TCR033144S011 K230844 000
M572TCR033145N011 K230844 000
M572TCR033145S011 K230844 000
M572TCR033126S011 K230844 000
M572TCR033126N011 K230844 000
M572TCR033125S011 K230844 000
M572TCR033106S011 K230844 000
M572TCR033107S011 K230844 000
M572TCR033121S011 K230844 000
M572TCR033122N011 K230844 000
M572TCR033122S011 K230844 000
M572TCR033123N011 K230844 000
M572TCR033123S011 K230844 000
M572TCR033124N011 K230844 000
M572TCR033124S011 K230844 000
M572TCR033125N011 K230844 000
M572TCR033146N011 K230844 000
M572TCR033146S011 K230844 000
M572TCR033181S011 K230844 000
M572TCR033182N011 K230844 000
M572TCR033182S011 K230844 000
M572TCR033183N011 K230844 000
M572TCR033183S011 K230844 000
M572TCR033184N011 K230844 000
M572TCR033184S011 K230844 000
M572TCR033185N011 K230844 000
M572TCR033185S011 K230844 000
M572TCR033186N011 K230844 000
M572TCR033167S011 K230844 000
M572TCR033166S011 K230844 000
M572TCR033166N011 K230844 000
M572TCR033147S011 K230844 000
M572TCR033161S011 K230844 000
M572TCR033162N011 K230844 000
M572TCR033162S011 K230844 000
M572TCR033163N011 K230844 000
M572TCR033163S011 K230844 000
M572TCR033164N011 K230844 000
M572TCR033164S011 K230844 000
M572TCR033165N011 K230844 000
M572TCR033165S011 K230844 000
M572TCR033186S011 K230844 000
M572TCR033105S011 K230844 000
M572TCR030184S011 K230844 000
M572TCR033065S011 K230844 000
M572TCR033066N011 K230844 000
M572TCR033066S011 K230844 000
M572TCR033067S011 K230844 000
M572TCR033071S011 K230844 000
M572TCR033072N011 K230844 000
M572TCR033072S011 K230844 000
M572TCR033073N011 K230844 000
M572TCR033073S011 K230844 000
M572TCR033074N011 K230844 000
M572TCR033065N011 K230844 000
M572TCR033064S011 K230844 000
M572TCR033064N011 K230844 000
M572TCR030185N011 K230844 000
M572TCR030185S011 K230844 000
M572TCR030186N011 K230844 000
M572TCR030186S011 K230844 000
M572TCR030187S011 K230844 000
M572TCR033061S011 K230844 000
M572TCR033062N011 K230844 000
M572TCR033062S011 K230844 000
M572TCR033063N011 K230844 000
M572TCR033063S011 K230844 000
M572TCR033074S011 K230844 000
M572TCR033075N011 K230844 000
M572TCR033086N011 K230844 000
M572TCR033086S011 K230844 000
M572TCR033087S011 K230844 000
M572TCR033101S011 K230844 000
M572TCR033102N011 K230844 000
M572TCR033102S011 K230844 000
M572TCR033103N011 K230844 000
M572TCR033103S011 K230844 000
M572TCR033104N011 K230844 000
M572TCR033104S011 K230844 000
M572TCR033085S011 K230844 000
M572TCR033085N011 K230844 000
M572TCR033084S011 K230844 000
M572TCR033075S011 K230844 000
M572TCR033076N011 K230844 000
M572TCR033076S011 K230844 000
M572TCR033077S011 K230844 000
M572TCR033081S011 K230844 000
M572TCR033082N011 K230844 000
M572TCR033082S011 K230844 000
M572TCR033083N011 K230844 000
M572TCR033083S011 K230844 000
M572TCR033084N011 K230844 000
M572TCR033105N011 K230844 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


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