Cleared Special

OLYMPIC CFM 6000

K031149 · Olympic Medical Corp. · Neurology

May 2003

Decision

34d

Days

Class 2

Risk

About This 510(k) Submission

K031149 is an FDA 510(k) clearance for the OLYMPIC CFM 6000, a Amplitude-integrated Electroencephalograph (Class II — Special Controls, product code OMA), submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on May 14, 2003, 34 days after receiving the submission on April 10, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K031149 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2003
Decision Date	May 14, 2003
Days to Decision	34 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMA — Amplitude-integrated Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	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).