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510(k) K080217

COMPONENT NEUROMONITORING SYSTEM by Moberg Research, Inc. — Product Code OMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2008
Date Received
January 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Moberg Research, Inc.

  • K192572 — CNS Envision (December 17, 2019)

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)
  • K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001 (June 16, 2010)