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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name encephalogram telemetry system
510(k) Number K871120
Device Name M10 EEG MONITOR SCOPE
Applicant
TELEDIAGNOSTIC SYSTEMS, INC.
2053 SUTTER ST.
SAN FRANCISCO,  CA  94115
Correspondent
TELEDIAGNOSTIC SYSTEMS, INC.
2053 SUTTER ST.
SAN FRANCISCO,  CA  94115
Regulation Number882.1855
Classification Product Code
GYE  
Date Received03/19/1987
Decision Date 05/01/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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