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 K240846

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
17290117356545 K240846 000
17290117356675 K240846 000
17290117356682 K240846 000
17290117356699 K240846 000
17290117356705 K240846 000
17290117356712 K240846 000
17290117356729 K240846 000
17290117356736 K240846 000
17290117356743 K240846 000
17290117356750 K240846 000
17290117356668 K240846 000
17290117356644 K240846 000
17290117356552 K240846 000
17290117356569 K240846 000
17290117356576 K240846 000
17290117356583 K240846 000
17290117356590 K240846 000
17290117356606 K240846 000
17290117356613 K240846 000
17290117356620 K240846 000
17290117356637 K240846 000
17290117356767 K240846 000
17290117356774 K240846 000
17290117356781 K240846 000
17290117355869 K240846 000
17290117355876 K240846 000
17290117355883 K240846 000
17290117355890 K240846 000
17290117355906 K240846 000
17290117355913 K240846 000
17290117355937 K240846 000
17290117355944 K240846 000
17290117355951 K240846 000
17290117355852 K240846 000
17290117355838 K240846 000
17290117356798 K240846 000
17290117356804 K240846 000
17290117356811 K240846 000
17290117356828 K240846 000
17290117356835 K240846 000
17290117356842 K240846 000
17290117356859 K240846 000
07290117355794 K240846 000
17290117355814 K240846 000
17290117355968 K240846 000
17290117353834 K240846 000
17290117353957 K240846 000
17290117353964 K240846 000
17290117353971 K240846 000
17290117353988 K240846 000
17290117354015 K240846 000
17290117354022 K240846 000
17290117354039 K240846 000
17290117354046 K240846 000
17290117354053 K240846 000
17290117353940 K240846 000
17290117353933 K240846 000
17290117353841 K240846 000
17290117353858 K240846 000
17290117353865 K240846 000
17290117353872 K240846 000
17290117353889 K240846 000
17290117353896 K240846 000
17290117353902 K240846 000
17290117353919 K240846 000
17290117353926 K240846 000
17290117354060 K240846 000
17290117354077 K240846 000
17290117354084 K240846 000
17290117354206 K240846 000
17290117356453 K240846 000
17290117356460 K240846 000
17290117356477 K240846 000
17290117356484 K240846 000
17290117356491 K240846 000
17290117356507 K240846 000
17290117356514 K240846 000
17290117356521 K240846 000
17290117354190 K240846 000
17290117354183 K240846 000
17290117354091 K240846 000
17290117354107 K240846 000
17290117354114 K240846 000
17290117354121 K240846 000
17290117354138 K240846 000
17290117354145 K240846 000
17290117354152 K240846 000
17290117354169 K240846 000
17290117354176 K240846 000
17290117356538 K240846 000
17290117352349 K240846 000
07290117353745 K240846 000
07290117353776 K240846 000
17290117352240 K240846 000
17290117352257 K240846 000
17290117352448 K240846 000
17290117352455 K240846 000
17290117352462 K240846 000
17290117352479 K240846 000
17290117352486 K240846 000
07290117353721 K240846 000
07290117353592 K240846 000
17290117352356 K240846 000
17290117352363 K240846 000
17290117352370 K240846 000
17290117352387 K240846 000
17290117352394 K240846 000
17290117352400 K240846 000
17290117352417 K240846 000
17290117352424 K240846 000
17290117352431 K240846 000
17290117352493 K240846 000
17290117352509 K240846 000
17290117352516 K240846 000
17290117352639 K240846 000
17290117352646 K240846 000
17290117352653 K240846 000
17290117352660 K240846 000
17290117352677 K240846 000
17290117352684 K240846 000
17290117352691 K240846 000
17290117352707 K240846 000
17290117352714 K240846 000
17290117352622 K240846 000
17290117352615 K240846 000
17290117352523 K240846 000
17290117352530 K240846 000
17290117352547 K240846 000
17290117352554 K240846 000
17290117352561 K240846 000
17290117352578 K240846 000
17290117352585 K240846 000
17290117352592 K240846 000
17290117352608 K240846 000
17290117353544 K240846 000
17290117355975 K240846 000
17290117356101 K240846 000
17290117356118 K240846 000
17290117356125 K240846 000
17290117356132 K240846 000
17290117356149 K240846 000
17290117356156 K240846 000
17290117356163 K240846 000
17290117356170 K240846 000
17290117356187 K240846 000
17290117356095 K240846 000
17290117356088 K240846 000
17290117355982 K240846 000
17290117355999 K240846 000
17290117356019 K240846 000
17290117356026 K240846 000
17290117356033 K240846 000
17290117356040 K240846 000
17290117356057 K240846 000
17290117356064 K240846 000
17290117356071 K240846 000
17290117356194 K240846 000
17290117356200 K240846 000
07290117352922 K240846 000
07290117352069 K240846 000
07290117352113 K240846 000
17290117352264 K240846 000
17290117352271 K240846 000
17290117352288 K240846 000
17290117352295 K240846 000
17290117352301 K240846 000
17290117352318 K240846 000
17290117352325 K240846 000
07290117352021 K240846 000
07290117352014 K240846 000
17290117352936 K240846 000
17290117352943 K240846 000
07290117353608 K240846 000
07290117351956 K240846 000
07290117351963 K240846 000
07290117351970 K240846 000
07290117351987 K240846 000
07290117351994 K240846 000
07290117352007 K240846 000
17290117352332 K240846 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.