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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reduced- Montage Standard Electroencephalograph
510(k) Number K020335
Device Name OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
Applicant
OLYMPIC MEDICAL CORP.
5900 FIRST AVE., SOUTH
SEATTLE,  WA  98108
Applicant Contact EDWARD B (TED) WEILER
Correspondent
OLYMPIC MEDICAL CORP.
5900 FIRST AVE., SOUTH
SEATTLE,  WA  98108
Correspondent Contact EDWARD B (TED) WEILER
Regulation Number882.1400
Classification Product Code
OMC  
Date Received02/01/2002
Decision Date 06/18/2002
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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