Advanced Brain Monitoring, Inc. is one of 18365 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Advanced Brain Monitoring, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Sleep Profiler, X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29), NIGHT SHIFT
14
Total
14
Cleared
0
Denied
Advanced Brain Monitoring, Inc. has 14 FDA 510(k) cleared medical devices. Based in Carlsbad, US.
Historical record: 14 cleared submissions from 2004 to 2016. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Advanced Brain Monitoring, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Pathway Regulatory Consulting, LLC as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Advanced Brain Monitoring, Inc.
14 devices
Cleared
Mar 14, 2016
Sleep Profiler
Neurology
110d
Cleared
Oct 30, 2015
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8...
Neurology
100d
Cleared
CT
May 29, 2014
NIGHT SHIFT
Ear, Nose, Throat
125d
Cleared
Nov 27, 2013
X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC...
Neurology
197d
Cleared
Apr 17, 2013
SLEEP PROFILER
Neurology
105d
Cleared
Jan 31, 2013
X4 SYSTEM
Neurology
29d
Cleared
Sep 19, 2012
SLEEP PROFILER
Neurology
218d
Cleared
Jun 20, 2012
X4
Neurology
127d
Cleared
Jan 09, 2012
APNEA RISK EVALUATION SYSTEM (ARES)
Anesthesiology
132d
Cleared
Jul 22, 2011
APNEA GUARD
Dental
93d
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