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 K201728

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
07899258607832 K201728 000
07899258608044 K201728 000
07899258608051 K201728 000
07899258608068 K201728 000
07899258608075 K201728 000
07899258608082 K201728 000
07899258608099 K201728 000
07899258608105 K201728 000
07899258608112 K201728 000
07899258608129 K201728 000
07899258608136 K201728 000
07899258608037 K201728 000
07899258608020 K201728 000
07899258608013 K201728 000
07899258607917 K201728 000
07899258607924 K201728 000
07899258607931 K201728 000
07899258607948 K201728 000
07899258607955 K201728 000
07899258607962 K201728 000
07899258607979 K201728 000
07899258607986 K201728 000
07899258607993 K201728 000
07899258608006 K201728 000
07899258608143 K201728 000
07899258608150 K201728 000
07899258609560 K201728 000
07899258609577 K201728 000
07899258659442 K201728 000
07899258600161 K201728 000
07899258600581 K201728 000
07899258600598 K201728 000
07899258600734 K201728 000
07899258600741 K201728 000
07899258600758 K201728 000
07899258600765 K201728 000
07899258609553 K201728 000
07899258609546 K201728 000
07899258609539 K201728 000
07899258608167 K201728 000
07899258608174 K201728 000
07899258608181 K201728 000
07899258608198 K201728 000
07899258608204 K201728 000
07899258608211 K201728 000
07899258609478 K201728 000
07899258609508 K201728 000
07899258609515 K201728 000
07899258609522 K201728 000
07899258600772 K201728 000
07899258607825 K201728 000
07899258636658 K201728 000
07899258654935 K201728 000
07899258654942 K201728 000
07899258654959 K201728 000
07899258654966 K201728 000
07899258654973 K201728 000
07899258654980 K201728 000
07899258654997 K201728 000
07899258655000 K201728 000
07899258655017 K201728 000
07899258655024 K201728 000
07899258654928 K201728 000
07899258654911 K201728 000
07899258654904 K201728 000
07899258654560 K201728 000
07899258654706 K201728 000
07899258607887 K201728 000
07899258607894 K201728 000
07899258607900 K201728 000
07899258654850 K201728 000
07899258654867 K201728 000
07899258654874 K201728 000
07899258654881 K201728 000
07899258654898 K201728 000
07899258655048 K201728 000
07899258655338 K201728 000
07899258657844 K201728 000
07899258657851 K201728 000
07899258657868 K201728 000
07899258657875 K201728 000
07899258657882 K201728 000
07899258657899 K201728 000
07899258657905 K201728 000
07899258657912 K201728 000
07899258657929 K201728 000
07899258601151 K201728 000
07899258657837 K201728 000
07899258657820 K201728 000
07899258657813 K201728 000
07899258657714 K201728 000
07899258657721 K201728 000
07899258657738 K201728 000
07899258657745 K201728 000
07899258657752 K201728 000
07899258657769 K201728 000
07899258657776 K201728 000
07899258657783 K201728 000
07899258657790 K201728 000
07899258657806 K201728 000
07899258607818 K201728 000
07899258600789 K201728 000
07899258609737 K201728 000
07899258600680 K201728 000
07899258600697 K201728 000
07899258600703 K201728 000
07899258600710 K201728 000
07899258600727 K201728 000
07899258600840 K201728 000
07899258600864 K201728 000
07899258612621 K201728 000
07899258612638 K201728 000
07899258612645 K201728 000
07899258600673 K201728 000
07899258600666 K201728 000
07899258600659 K201728 000
07899258609744 K201728 000
07899258609751 K201728 000
07899258609768 K201728 000
07899258655031 K201728 000
07899258600574 K201728 000
07899258600604 K201728 000
07899258600611 K201728 000
07899258600628 K201728 000
07899258600635 K201728 000
07899258600642 K201728 000
07899258612652 K201728 000
07899258612669 K201728 000
07899258612805 K201728 000
07899258612812 K201728 000
07899258612829 K201728 000
07899258612836 K201728 000
07899258612843 K201728 000
07899258616568 K201728 000
07899258632384 K201728 000
07899258654614 K201728 000
07899258654621 K201728 000
07899258654683 K201728 000
07899258612799 K201728 000
07899258612782 K201728 000
07899258612775 K201728 000
07899258612676 K201728 000
07899258612683 K201728 000
07899258612690 K201728 000
07899258612706 K201728 000
07899258612713 K201728 000
07899258612720 K201728 000
07899258612737 K201728 000
07899258612744 K201728 000
07899258612751 K201728 000
07899258612768 K201728 000
07899258657936 K201728 000
07899258609720 K201728 000
07899258600796 K201728 000
07899258600963 K201728 000
07899258600970 K201728 000
07899258601014 K201728 000
07899258601021 K201728 000
07899258601038 K201728 000
07899258601045 K201728 000
07899258601052 K201728 000
07899258601069 K201728 000
07899258601076 K201728 000
07899258601083 K201728 000
07899258600956 K201728 000
07899258600949 K201728 000
07899258600932 K201728 000
07899258600802 K201728 000
07899258600819 K201728 000
07899258600826 K201728 000
07899258600833 K201728 000
07899258600857 K201728 000
07899258600871 K201728 000
07899258600895 K201728 000
07899258600901 K201728 000
07899258600918 K201728 000
07899258600925 K201728 000
07899258601090 K201728 000
07899258601106 K201728 000
07899258609614 K201728 000
07899258609621 K201728 000
07899258609638 K201728 000
07899258609645 K201728 000
07899258609652 K201728 000
07899258609669 K201728 000
07899258609676 K201728 000
07899258609683 K201728 000
07899258609690 K201728 000
07899258609706 K201728 000
07899258609607 K201728 000
07899258609591 K201728 000
07899258609584 K201728 000
07899258601113 K201728 000
07899258601120 K201728 000
07899258601137 K201728 000
07899258601144 K201728 000
07899258601168 K201728 000
07899258601175 K201728 000
07899258601182 K201728 000
07899258601199 K201728 000
07899258601205 K201728 000
07899258601212 K201728 000
07899258609713 K201728 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.