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 K250845

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
B648C72540281620T0 K250845 000
B648C725520150 K250845 000
B648C725520200 K250845 000
B648C7258310 K250845 000
B648C7259000 K250845 000
B648C72510000 K250845 000
B648C725101150 K250845 000
B648C7251500 K250845 000
B648C7253010 K250845 000
B648C725500150 K250845 000
B648C725500200 K250845 000
B648C725530150 K250845 000
B648C725530200 K250845 000
B648C725511200 K250845 000
B648C725511150 K250845 000
B648C72540281625T0 K250845 000
B648C7254028168T0 K250845 000
B648C72540281814T0 K250845 000
B648C72540281820T0 K250845 000
B648C72540281825T0 K250845 000
B648C7254028188T0 K250845 000
B648C72540282014T0 K250845 000
B648C72540282020T0 K250845 000
B648C72540282025T0 K250845 000
B648C7254028208T0 K250845 000
B648C725510150 K250845 000
B648C725510200 K250845 000
B648C7253024108T0 K250845 000
B648C7253526108T0 K250845 000
B648C724302418201 K250845 000
B648C724302418251 K250845 000
B648C724302418301 K250845 000
B648C72430241881 K250845 000
B648C724302420141 K250845 000
B648C724302420201 K250845 000
B648C724302420251 K250845 000
B648C724302420301 K250845 000
B648C72430242081 K250845 000
B648C724352610141 K250845 000
B648C72435261081 K250845 000
B648C724352612141 K250845 000
B648C724302418141 K250845 000
B648C724302416301 K250845 000
B648C7254028108T0 K250845 000
B648C724302410141 K250845 000
B648C724302412141 K250845 000
B648C724302412201 K250845 000
B648C72430241281 K250845 000
B648C724302414141 K250845 000
B648C724302414201 K250845 000
B648C724302414251 K250845 000
B648C72430241481 K250845 000
B648C724302416141 K250845 000
B648C724302416201 K250845 000
B648C724302416251 K250845 000
B648C72435261281 K250845 000
B648C72540281614T0 K250845 000
B648C72540281420T0 K250845 000
B648C7253024128T0 K250845 000
B648C72530241414T0 K250845 000
B648C72530241420T0 K250845 000
B648C72530241425T0 K250845 000
B648C7253024148T0 K250845 000
B648C72530241614T0 K250845 000
B648C72530241620T0 K250845 000
B648C72530241625T0 K250845 000
B648C7253024168T0 K250845 000
B648C72530241814T0 K250845 000
B648C72530241820T0 K250845 000
B648C72530241825T0 K250845 000
B648C72530241220T0 K250845 000
B648C72530241214T0 K250845 000
B648C2959000 K250845 000
B648C72430241081 K250845 000
B648C7245020VSD0 K250845 000
B648C725050 K250845 000
B648C7251000 K250845 000
B648C725101200 K250845 000
B648C725101250 K250845 000
B648C725101300 K250845 000
B648C725130N0 K250845 000
B648C7252000 K250845 000
B648C7253020 K250845 000
B648C72530241014T0 K250845 000
B648C7253024188T0 K250845 000
B648C72530242014T0 K250845 000
B648C72535261814T0 K250845 000
B648C72535261820T0 K250845 000
B648C72535261825T0 K250845 000
B648C7253526188T0 K250845 000
B648C72535262014T0 K250845 000
B648C72535262020T0 K250845 000
B648C72535262025T0 K250845 000
B648C7253526208T0 K250845 000
B648C72540281014T0 K250845 000
B648C72540281214T0 K250845 000
B648C7254028128T0 K250845 000
B648C72540281414T0 K250845 000
B648C7253526168T0 K250845 000
B648C72535261625T0 K250845 000
B648C72530242020T0 K250845 000
B648C72530242025T0 K250845 000
B648C7253024208T0 K250845 000
B648C7253030 K250845 000
B648C72535261014T0 K250845 000
B648C72535261214T0 K250845 000
B648C7253526128T0 K250845 000
B648C72535261414T0 K250845 000
B648C72535261420T0 K250845 000
B648C7253526148T0 K250845 000
B648C72535261614T0 K250845 000
B648C72535261620T0 K250845 000
B648C7254028148T0 K250845 000
B648C724352614141 K250845 000
B648C724352616251 K250845 000
B648C724402816251 K250845 000
B648C72440281681 K250845 000
B648C724402818141 K250845 000
B648C724402818201 K250845 000
B648C724402818251 K250845 000
B648C72440281881 K250845 000
B648C724402820141 K250845 000
B648C724402820201 K250845 000
B648C724402820251 K250845 000
B648C72440282081 K250845 000
B648C7245020FSD0 K250845 000
B648C7245020FST0 K250845 000
B648C724402816201 K250845 000
B648C724402816141 K250845 000
B648C724352618251 K250845 000
B648C724352618301 K250845 000
B648C724352620201 K250845 000
B648C724352620251 K250845 000
B648C724352620301 K250845 000
B648C724402810141 K250845 000
B648C72440281081 K250845 000
B648C724402812141 K250845 000
B648C72440281281 K250845 000
B648C724402814141 K250845 000
B648C724402814201 K250845 000
B648C72440281481 K250845 000
B648C7245020VST0 K250845 000
B648C7245025FSD0 K250845 000
B648C7245520VST0 K250845 000
B648C7245525FSD0 K250845 000
B648C7245525FST0 K250845 000
B648C7245525VSD0 K250845 000
B648C7245525VST0 K250845 000
B648C7245530FSD0 K250845 000
B648C7245530FST0 K250845 000
B648C7245530VSD0 K250845 000
B648C7245530VST0 K250845 000
B648C7245535FSD0 K250845 000
B648C7245535FST0 K250845 000
B648C7245535VSD0 K250845 000
B648C7245520VSD0 K250845 000
B648C7245520FST0 K250845 000
B648C7245025FST0 K250845 000
B648C7245025VSD0 K250845 000
B648C7245025VST0 K250845 000
B648C7245030FSD0 K250845 000
B648C7245030FST0 K250845 000
B648C7245030VSD0 K250845 000
B648C7245030VST0 K250845 000
B648C7245035FSD0 K250845 000
B648C7245035FST0 K250845 000
B648C7245035VSD0 K250845 000
B648C7245035VST0 K250845 000
B648C7245520FSD0 K250845 000
B648C7245535VST0 K250845 000
B648C72430241681 K250845 000
B648C724352614201 K250845 000
B648C725600200 K250845 000
B648C725600250 K250845 000
B648C725600300 K250845 000
B648C725600350 K250845 000
B648C725610150 K250845 000
B648C725610200 K250845 000
B648C725620150 K250845 000
B648C725620200 K250845 000
B648C7256300 K250845 000
B648C725633150 K250845 000
B648C725633200 K250845 000
B648C725633250 K250845 000
B648C725600150 K250845 000
B648C7254000 K250845 000
B648C72435261481 K250845 000
B648C724352616141 K250845 000
B648C724352616201 K250845 000
B648C72435261681 K250845 000
B648C724352618141 K250845 000
B648C724352618201 K250845 000
B648C72435261881 K250845 000
B648C724352620141 K250845 000
B648C72435262081 K250845 000
B648C7251050 K250845 000
B648C72511000 K250845 000
B648C7252010 K250845 000
B648C725633300 K250845 000
B648C725633350 K250845 000
B648C725720350 K250845 000
B648C725733150 K250845 000
B648C725733200 K250845 000
B648C725733250 K250845 000
B648C725733300 K250845 000
B648C725733350 K250845 000
B648C7258000 K250845 000
B648C7258100 K250845 000
B648C7258200 K250845 000
B648C7258300 K250845 000
B648C725833L0 K250845 000
B648C725833S0 K250845 000
B648C725720300 K250845 000
B648C725720250 K250845 000
B648C725700150 K250845 000
B648C725700200 K250845 000
B648C725700250 K250845 000
B648C725700300 K250845 000
B648C725700350 K250845 000
B648C725710150 K250845 000
B648C725710200 K250845 000
B648C725710250 K250845 000
B648C725710300 K250845 000
B648C725710350 K250845 000
B648C725720150 K250845 000
B648C725720200 K250845 000
B648C7258400 K250845 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.