510(k) K093949

OLYMPIC BRAINZ MONITOR MODEL OBM70001 by Natus Medical, Inc. — Product Code OMA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 16, 2010
Date Received: December 23, 2009
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Amplitude-Integrated Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

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).

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Other clearances for product code OMA

K192889 — Neo (January 30, 2020)
K163644 — Nihon Kohden QP-160AK EEG Trend Program (May 19, 2017)
K161027 — Cadwell AmpliScan (November 8, 2016)
K152301 — Background Pattern Classification [BPc(TM)] (June 3, 2016)
K130238 — NIHON KOHDEN AE-918P NEURO UNIT (March 4, 2015)
K131789 — CEREBRALOGIK- AEEG (December 27, 2013)
K123079 — OLYMPIC BRAINZ MONITOR (May 8, 2013)
K120485 — NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AN (March 16, 2012)
K092573 — NIHON KOHDEN QP-160AK EEG TREND PROGRAM (July 9, 2010)
K081551 — TWIN NEUROTRAC-III (December 24, 2008)