510(k) K130238

NIHON KOHDEN AE-918P NEURO UNIT by Nihon Kohden Corp. — Product Code OMA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 4, 2015
Date Received: January 31, 2013
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

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K161027 — Cadwell AmpliScan (November 8, 2016)
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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)
K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001 (June 16, 2010)
K081551 — TWIN NEUROTRAC-III (December 24, 2008)