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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplitude-Integrated Electroencephalograph
510(k) Number K983229
Device Name OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM
Applicant
Olympic Medical Corp.
5900 First Ave. S.
Seattle,  WA  98108
Applicant Contact EDWARD (TED) B WEILER
Correspondent
Olympic Medical Corp.
5900 First Ave. S.
Seattle,  WA  98108
Correspondent Contact EDWARD (TED) B WEILER
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Code
OMC  
Date Received09/15/1998
Decision Date 03/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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