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Advanced Brain Monitoring, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K172799Positional Sleep Assessment System (PoSAS) softwareMarch 9, 2018
K153412Sleep ProfilerMarch 14, 2016
K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29October 30, 2015
K140190NIGHT SHIFTMay 29, 2014
K131383X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARENovember 27, 2013
K130007SLEEP PROFILERApril 17, 2013
K130013X4 SYSTEMJanuary 31, 2013
K120450SLEEP PROFILERSeptember 19, 2012
K120447X4June 20, 2012
K112514APNEA RISK EVALUATION SYSTEM (ARES)January 9, 2012
K111110APNEA GUARDJuly 22, 2011
K111194APNEA RISK EVALUATION SYSTEM (ARES)July 7, 2011
K110705APNEA RISK EVALUATION SYSTEM (ARES)April 14, 2011
K071230APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600October 3, 2007
K041662APNEA RISK EVALUATION SYSTEM (ARES)October 14, 2004