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510(k) K071449

BRM3 BRAIN MONITOR by Brainz Instruments , Ltd. — Product Code OMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2007
Date Received
May 24, 2007
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 Brainz Instruments , Ltd.

  • K033010 — BRM2 BRAIN MONITOR (October 10, 2003)
  • K030489 — BRM2 BRAIN MONITOR (May 2, 2003)

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  • 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)