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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 K970659
Device Name DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
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 Received02/21/1997
Decision Date 05/16/1997
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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