FDA Product Code OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By Qualified User
Leading manufacturers include Advanced Brain Monitoring, Inc., Embla Systems and Beacon Biosignals, Inc..
37
Total
37
Cleared
178d
Avg days
1986
Since
37 devices
Cleared
Sep 19, 2012
SLEEP PROFILER
Advanced Brain Monitoring, Inc.
Neurology
218d
Cleared
Apr 19, 2011
NATUS SLEEPWORKS, MODEL 104017
Excel-Tech Ltd. (Xltek)
Neurology
804d
Cleared
May 09, 2007
POLYSMITH SLEEP SYSTEM, MODEL NTI5498
Neurotronics, Inc.
Neurology
223d
Cleared
Mar 18, 2004
ALICE 5
Respironics, Inc.
Neurology
10d
Cleared
Apr 02, 1997
SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
Omega Results
Neurology
203d
Cleared
Jan 17, 1997
MEDILOG VISION
Oxford Instruments, Plc.
Neurology
263d
Cleared
Oct 26, 1992
SENSORMEDICS 4000 SERIES SLEEP SYSTEM
Sensor Medics Corp.
Neurology
304d
Cleared
Jun 01, 1989
MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM
Oxford Medilog, Inc.
Neurology
84d
Cleared
Oct 07, 1987
MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.
Oxford Medilog, Inc.
Neurology
134d