FDA Product Code OMB: Automatic Event Detection Software For Full-montage Electroencephalograph
Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User
Leading manufacturers include Persyst Development Corporation, Ceribell, Inc. and Excel Tech. , Ltd..
42
Total
42
Cleared
157d
Avg days
1987
Since
42 devices
Cleared
Jul 23, 2014
CADWELL SPIKE AND SEIZURE DETECTOR
Cadwell
Neurology
141d
Cleared
May 19, 2014
PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE
Persyst Development Corporation
Neurology
157d
Cleared
Nov 21, 2013
PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
Persyst Development Corp.
Neurology
120d
Cleared
Jun 29, 2012
ICTA
Excel-Tech Ltd. (Xltek)
Neurology
154d
Cleared
Feb 22, 2010
NATUS NEUROWORKS, MODEL 104196
Natus Medical, Inc.
Neurology
416d
Cleared
Oct 16, 2009
IDENTEVENT, VERSION 1.0G
Optima Neuroscience, Inc.
Neurology
102d
Cleared
Sep 16, 2004
XLTEK CONNEX IP HEADBOX, MODEL 1054
Excel Tech. , Ltd.
Neurology
30d
Cleared
Aug 03, 2001
PERSYST REVEAL
Persyst Development Corp.
Neurology
88d
Cleared
Mar 15, 2001
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
Excel Tech. , Ltd.
Neurology
63d
Cleared
Oct 06, 2000
EEG SPIKE AND EVENT DETECTOR MODULE
Excel Tech. , Ltd.
Neurology
66d
Cleared
Apr 04, 1996
HARMONIE SENSA
Stellate Systems
Neurology
76d
Cleared
Feb 09, 1996
DIGITRACE HOME VIDEO SYSTEM
New England Medical Instruments, Inc.
Neurology
50d
Cleared
Aug 22, 1995
BIO-LOGIC AUTOMATIC EVENT ANALYSIS
Bio-Logic Systems Corp.
Neurology
138d