FDA.reportPublic FDA data

Advanced-Brain-Monitoring

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049647383004964738ADVANCED BRAIN MONITORING, INC.1N2026-01-012237 FARADAY AVE STE 100 CARLSBAD CA US 92008

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
636871578210498K172799Positional Sleep Assessment System (PoSAS) softwareMNR2018-03-09
636871906245353K153412Sleep ProfilerOLZ2016-03-14
636871746718956K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)OMC2015-10-30
636871888173747K140190NIGHT SHIFTMYB2014-05-29
636871385374485K131383X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWAREGWQ2013-11-27
636871092844538K130013X4 SYSTEMOMC2013-01-31
636871277411630K130007SLEEP PROFILEROLZ2013-04-17
636871987699126K120450SLEEP PROFILEROLZ2012-09-19
636871924789107K120447X4OMC2012-06-20
636871452550372K111110APNEA GUARDLRK2011-07-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLZ32016-03-14
OMC32015-10-30
MNR12018-03-09
MYB12014-05-29
GWQ12013-11-27
LRK12011-07-22

PMN#

X4 SYSTEM

2013-01-31

ADVANCED BRAIN MONITORING INC.

X4

2012-06-20

ADVANCED BRAIN MONITORING, INC.

GUDID#

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