Medical Device Manufacturer · US , Carlsbad , CA

Advanced Brain Monitoring, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2004

Recent clearances: Sleep Profiler, X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29), NIGHT SHIFT

View 14 510(k) Devices ↓

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Advanced Brain Monitoring, Inc. Anesthesiology ✕

5 devices

1-5 of 5

Cleared Jan 09, 2012

APNEA RISK EVALUATION SYSTEM (ARES)

Anesthesiology · 132d

Cleared Jul 07, 2011

APNEA RISK EVALUATION SYSTEM (ARES)

Anesthesiology · 70d

Cleared Apr 14, 2011

APNEA RISK EVALUATION SYSTEM (ARES)

Anesthesiology · 31d

Cleared Oct 03, 2007

APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600

Anesthesiology · 153d

Cleared Oct 14, 2004

APNEA RISK EVALUATION SYSTEM (ARES)

Anesthesiology · 118d