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510(k) K120485

NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P by Nihon Kohden America, Inc. — Product Code OMA

K120485 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P". The FDA issued a decision of Substantially Equivalent on March 16, 2012. The device falls under product code OMA (Amplitude-Integrated Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2012
Date Received
February 17, 2012
Clearance Type
Special
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)
  • K092573 — NIHON KOHDEN QP-160AK EEG TREND PROGRAM (July 9, 2010)
  • 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)
  • 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)

FDA data resources