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 K232256

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
B030SAZ6055VT0 K232256 000
B030SAZ6035FT0 K232256 000
B030SAZ6035FD0 K232256 000
B030SAZ6030VT0 K232256 000
B030SAZ6030VD0 K232256 000
B030SAZ6030FT0 K232256 000
B030SAZ6030FD0 K232256 000
B030SAZ6025VT0 K232256 000
B030SAZ6025VD0 K232256 000
B030SAZ6025FT0 K232256 000
B030SAZ6025FD0 K232256 000
B030SAZ6020VT0 K232256 000
B030SAZ6020VD0 K232256 000
B030SAZ6020FT0 K232256 000
B030SAZ6020FD0 K232256 000
B030SAZ6035VD0 K232256 000
B030SAZ6035VT0 K232256 000
B030SAZ6040FD0 K232256 000
B030SAZ6055VD0 K232256 000
B030SAZ6055FT0 K232256 000
B030SAZ6055FD0 K232256 000
B030SAZ6050VT0 K232256 000
B030SAZ6050VD0 K232256 000
B030SAZ6050FT0 K232256 000
B030SAZ6050FD0 K232256 000
B030SAZ6045VT0 K232256 000
B030SAZ6045VD0 K232256 000
B030SAZ6045FT0 K232256 000
B030SAZ6045FD0 K232256 000
B030SAZ6040VT0 K232256 000
B030SAZ6040VD0 K232256 000
B030SAZ6040FT0 K232256 000
B030SAZ5560VT0 K232256 000
B030SAZ5560VD0 K232256 000
B030SAZ5520VT0 K232256 000
B030SAZ5520VD0 K232256 000
B030SAZ5520FT0 K232256 000
B030SAZ5560FT0 K232256 000
B030SAZ5555FT0 K232256 000
B030SAZ5550FT0 K232256 000
B030SAZ5545FT0 K232256 000
B030SAZ5540FT0 K232256 000
B030SAZ5535FT0 K232256 000
B030SAZ5535FD0 K232256 000
B030SAZ5530FT0 K232256 000
B030SAZ5530FD0 K232256 000
B030SAZ5525FT0 K232256 000
B030SAZ5525FD0 K232256 000
B030SAZ5525VD0 K232256 000
B030SAZ5525VT0 K232256 000
B030SAZ5530VD0 K232256 000
B030SAZ5560FD0 K232256 000
B030SAZ5555VT0 K232256 000
B030SAZ5555VD0 K232256 000
B030SAZ5555FD0 K232256 000
B030SAZ5550VT0 K232256 000
B030SAZ5550VD0 K232256 000
B030SAZ5550FD0 K232256 000
B030SAZ5545VT0 K232256 000
B030SAZ5545VD0 K232256 000
B030SAZ5540VT0 K232256 000
B030SAZ5540VD0 K232256 000
B030SAZ5535VT0 K232256 000
B030SAZ5535VD0 K232256 000
B030SAZ5530VT0 K232256 000
B030SAZ5520FD0 K232256 000
B030TLP424WL0 K232256 000
B030TLP4400 K232256 000
B030TLP438WL0 K232256 000
B030TLP438W0 K232256 000
B030TLP4380 K232256 000
B030TLP436WL0 K232256 000
B030TLP436W0 K232256 000
B030TLP4360 K232256 000
B030TLP434WL0 K232256 000
B030TLP434W0 K232256 000
B030TLP4340 K232256 000
B030TLP432WL0 K232256 000
B030TLP432W0 K232256 000
B030TLP4320 K232256 000
B030TLP430WL0 K232256 000
B030TLP440W0 K232256 000
B030TLP440WL0 K232256 000
B030TLP45200 K232256 000
B030TLP422WL0 K232256 000
B030TLP420WL0 K232256 000
B030SAZ5545FD0 K232256 000
B030SAZ5540FD0 K232256 000
B030TLP45400 K232256 000
B030TLP45380 K232256 000
B030TLP45360 K232256 000
B030TLP45340 K232256 000
B030TLP45320 K232256 000
B030TLP45300 K232256 000
B030TLP45280 K232256 000
B030TLP45260 K232256 000
B030TLP45240 K232256 000
B030TLP45220 K232256 000
B030TLP430W0 K232256 000
B030TLP4300 K232256 000
B030TLP25200 K232256 000
B030TLP25180 K232256 000
B030TLP2350 K232256 000
B030TLP2280 K232256 000
B030TLP2260 K232256 000
B030TLP2240 K232256 000
B030TLP2220 K232256 000
B030TLP2200 K232256 000
B030TLP2180 K232256 000
B030TLP1000 K232256 000
B030TLP013010 K232256 000
B030SAZ6060VT0 K232256 000
B030SAZ6060VD0 K232256 000
B030SAZ6060FT0 K232256 000
B030TLP25220 K232256 000
B030TLP25240 K232256 000
B030TLP25260 K232256 000
B030TLP428WL0 K232256 000
B030TLP428W0 K232256 000
B030TLP4280 K232256 000
B030TLP426WL0 K232256 000
B030TLP426W0 K232256 000
B030TLP4260 K232256 000
B030TLP424W0 K232256 000
B030TLP4240 K232256 000
B030TLP422W0 K232256 000
B030TLP4220 K232256 000
B030TLP420W0 K232256 000
B030TLP4200 K232256 000
B030TLP418W0 K232256 000
B030TLP4180 K232256 000
B030SAZ6060FD0 K232256 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


© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.