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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 K883947
Device Name ISO-100 ISOLATION AMPLIFIER
Applicant
TELEDIAGNOSTIC SYSTEMS, INC.
2053 SUTTER ST.
SAN FRANCISCO,  CA  94115
Applicant Contact LARRY WOODARD
Correspondent
TELEDIAGNOSTIC SYSTEMS, INC.
2053 SUTTER ST.
SAN FRANCISCO,  CA  94115
Correspondent Contact LARRY WOODARD
Regulation Number882.1855
Classification Product Code
GYE  
Date Received09/19/1988
Decision Date 12/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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