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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 NORTH AVIADOR ST.
camarillo,  CA  93010
Applicant Contact j. d harris
Correspondent
ZYMED MEDICAL INSTRUMENTATION
20 NORTH 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
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