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510(k) K093949

OLYMPIC BRAINZ MONITOR MODEL OBM70001 by Natus Medical, Inc. — Product Code OMA

K093949 is an FDA 510(k) premarket notification submitted by Natus Medical, Inc. for the device "OLYMPIC BRAINZ MONITOR MODEL OBM70001". The FDA issued a decision of Substantially Equivalent on June 16, 2010. The device falls under product code OMA (Amplitude-Integrated Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Natus Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2010
Date Received
December 23, 2009
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 Natus Medical, Inc.

  • K093304 — PROTEKTOR 32 (August 11, 2010)
  • K090019 — NATUS NEUROWORKS, MODEL 104196 (February 22, 2010)
  • K083371 — NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) (December 8, 2009)
  • K073665 — ALGO 5 NEWBORN HEARING SCREENER (January 25, 2008)
  • K051869 — NEOBLUE COZY LED PHOTOTHERAPY SYSTEM (October 7, 2005)
  • K030823 — ALGO 3I NEWBORN HEARING SCREENER (April 9, 2003)
  • K022196 — NATUS BLUE LIGHT PHOTOTHERAPY UNIT (September 19, 2002)
  • K013137 — ALGO 3 NEWBORN HEARING SCREENER (October 16, 2001)
  • K974805 — CO-STAT(TM) END TIDAL BREATH ANALYZER (March 11, 1998)
  • K935160 — MINIMUFFS (February 9, 1995)

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)
  • K081551 — TWIN NEUROTRAC-III (December 24, 2008)

FDA data resources