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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K951370
Device Name ZYMED TELEMETRY SYSTEM; MODEL T8010
Applicant
Zymed Medical Instrumentation
20 N. Aviador St.
Camarillo,  CA  93010
Applicant Contact J. D HARRIS
Correspondent
Zymed Medical Instrumentation
20 N. Aviador St.
Camarillo,  CA  93010
Correspondent Contact J. D HARRIS
Regulation Number870.1025
Classification Product Code
DSI  
Date Received03/27/1995
Decision Date 10/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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