OMA · Class II · 21 CFR 882.1400

FDA Product Code OMA: Amplitude-integrated Electroencephalograph

Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner).

Leading manufacturers include Olympic Medical Corp., Nihon Kohden America, Inc. and Cadwell Industries, Inc..

16
Total
16
Cleared
206d
Avg days
1979
Since

FDA 510(k) Cleared Amplitude-integrated Electroencephalograph Devices (Product Code OMA)

16 devices
1–16 of 16
Cleared Jan 30, 2020
Neo
K192889
Eemagine Medical Imaging Solutions GmbH
Neurology · 112d
Cleared May 19, 2017
Nihon Kohden QP-160AK EEG Trend Program
K163644
Nihon Kohden Corporation
Neurology · 147d
Cleared Nov 08, 2016
Cadwell AmpliScan
K161027
Cadwell Industries, Inc.
Neurology · 210d
Cleared Jun 03, 2016
Background Pattern Classification [BPc(TM)]
K152301
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Neurology · 294d
Cleared Mar 04, 2015
NIHON KOHDEN AE-918P NEURO UNIT
K130238
Nihon Kohden Corp.
Neurology · 762d
Cleared Dec 27, 2013
CEREBRALOGIK- AEEG
K131789
Mennen Medical , Ltd.
Neurology · 192d
Cleared May 08, 2013
OLYMPIC BRAINZ MONITOR
K123079
Excel-Tech Ltd. (Xltek)
Neurology · 219d
Cleared Mar 16, 2012
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
K120485
Nihon Kohden America, Inc.
Neurology · 28d
Cleared Jul 09, 2010
NIHON KOHDEN QP-160AK EEG TREND PROGRAM
K092573
Nihon Kohden America, Inc.
Neurology · 323d
Cleared Jun 16, 2010
OLYMPIC BRAINZ MONITOR MODEL OBM70001
K093949
Natus Medical, Inc.
Neurology · 175d
Cleared Dec 24, 2008
TWIN NEUROTRAC-III
K081551
Astro-Med, Inc.
Neurology · 204d
Cleared Nov 05, 2008
COMPONENT NEUROMONITORING SYSTEM
K080217
Moberg Research, Inc.
Neurology · 281d
Cleared Sep 14, 2007
BRM3 BRAIN MONITOR
K071449
Brainz Instruments , Ltd.
Neurology · 113d
Cleared May 14, 2003
OLYMPIC CFM 6000
K031149
Olympic Medical Corp.
Neurology · 34d
Cleared Mar 23, 1999
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM
K983229
Olympic Medical Corp.
Neurology · 189d
Cleared Sep 04, 1979
CEREBRAL FUNCTION MONITOR 870
K791580
Applied Medical Research
Neurology · 18d

About Product Code OMA - Regulatory Context