510(k) K031149

OLYMPIC CFM 6000 by Olympic Medical Corp. — Product Code OMA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 14, 2003
Date Received: April 10, 2003
Clearance Type: Special
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 Olympic Medical Corp.

K081094 — OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 (June 20, 2008)
K020335 — OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 (June 18, 2002)
K001056 — OLYMPIC WARM-UP (September 29, 2000)
K983229 — OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM (March 23, 1999)
K971601 — OLYMPIC BILI-BASSINET (September 24, 1997)
K972193 — OLYMPIX MINI-PASTEURMATIC (58210) (September 5, 1997)
K971117 — WARMETTE (August 22, 1997)
K955357 — OLYMPIC SMART SCALE MODEL 50/50RA (January 30, 1996)
K954434 — OLYMPIC INFANT THERMOMETER (December 20, 1995)
K954846 — OLYMPIC SMART SCALE (December 14, 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)
K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001 (June 16, 2010)