Home / 510(k) Clearances / K071449

510(k) K071449

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

K071449 is an FDA 510(k) premarket notification submitted by Brainz Instruments , Ltd. for the device "BRM3 BRAIN MONITOR". The FDA issued a decision of Substantially Equivalent on September 14, 2007. The device falls under product code OMA (Amplitude-Integrated Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Brainz Instruments , Ltd. has at least 2 other 510(k) clearances on record.

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)

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)

FDA data resources