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510(k) K130238

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

K130238 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corp. for the device "NIHON KOHDEN AE-918P NEURO UNIT". The FDA issued a decision of Substantially Equivalent on March 4, 2015. The device falls under product code OMA (Amplitude-Integrated Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Nihon Kohden Corp. has at least 10 other 510(k) clearances on record.

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).

Other clearances by Nihon Kohden Corp.

  • K151080 — Nihon Kohden CSM 1901 Bedside Monitor (November 5, 2015)
  • K122214 — TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) (May 21, 2013)
  • K120888 — PSG-1100 SLEEP DIAGNOSTIC SYSTEM (November 9, 2012)
  • K120397 — MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM (September 19, 2012)
  • K112637 — NETKONNECT REMOTE NETWORK EXTENSION (December 9, 2011)
  • K110594 — GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS (October 28, 2011)
  • K110410 — MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) (August 4, 2011)
  • K110376 — PE-210AK SWITCH BOX (July 29, 2011)
  • K102106 — NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION (December 17, 2010)
  • K102376 — NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 (December 7, 2010)

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

FDA data resources