510(k) K092573

NIHON KOHDEN QP-160AK EEG TREND PROGRAM by Nihon Kohden America, Inc. — Product Code OMA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 9, 2010
Date Received: August 20, 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).

Other clearances by Nihon Kohden America, Inc.

K113117 — NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX (March 22, 2012)
K120485 — NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AN (March 16, 2012)
K083456 — NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P (March 2, 2009)
K083271 — BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SER (December 24, 2008)
K082785 — NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES (November 26, 2008)
K071969 — SEN-4100 ELECTRIC STIMULATOR (October 6, 2008)
K080546 — NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A (August 29, 2008)
K073550 — PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION (March 28, 2008)
K080342 — NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES (February 26, 2008)
K073491 — EEG-1100A SWITCH BOX (January 11, 2008)

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)
K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001 (June 16, 2010)
K081551 — TWIN NEUROTRAC-III (December 24, 2008)