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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., SOUTH
SEATTLE,  WA  98108
Applicant Contact EDWARD (TED) B WEILER
Correspondent
OLYMPIC MEDICAL CORP.
5900 FIRST AVE., SOUTH
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
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