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OMA — Amplitude-Integrated Electroencephalograph Class II

FDA Device Classification

FDA product code OMA covers "Amplitude-Integrated Electroencephalograph", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 16 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
OMA
Device Class
Class II
Regulation Number
882.1400
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

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).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K192889eemagine medical imaging solutionsNeoJanuary 30, 2020
K163644nihon kohden corporationNihon Kohden QP-160AK EEG Trend ProgramMay 19, 2017
K161027cadwell industriesCadwell AmpliScanNovember 8, 2016
K152301natus medical incorporated dba excel-tech ltd. (xltek)Background Pattern Classification [BPc(TM)]June 3, 2016
K130238nihon kohdenNIHON KOHDEN AE-918P NEURO UNITMarch 4, 2015
K131789mennen medicalCEREBRALOGIK- AEEGDecember 27, 2013
K123079excel-tech ltd. (xltek)OLYMPIC BRAINZ MONITORMay 8, 2013
K120485nihon kohden americaNIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND ANMarch 16, 2012
K092573nihon kohden americaNIHON KOHDEN QP-160AK EEG TREND PROGRAMJuly 9, 2010
K093949natus medicalOLYMPIC BRAINZ MONITOR MODEL OBM70001June 16, 2010
K081551astro-medTWIN NEUROTRAC-IIIDecember 24, 2008
K080217moberg researchCOMPONENT NEUROMONITORING SYSTEMNovember 5, 2008
K071449brainz instrumentsBRM3 BRAIN MONITORSeptember 14, 2007
K031149olympic medicalOLYMPIC CFM 6000May 14, 2003
K983229olympic medicalOLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEMMarch 23, 1999
K791580applied medical researchCEREBRAL FUNCTION MONITOR 870September 4, 1979

FDA data resources