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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 K984089
Device Name ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW
Applicant
ZYMED MEDICAL INSTRUMENTATION
20 NORTH AVIADOR ST.
CAMARILLO,  CA  93010
Applicant Contact DUDLEY HARRIS
Correspondent
ZYMED MEDICAL INSTRUMENTATION
20 NORTH AVIADOR ST.
CAMARILLO,  CA  93010
Correspondent Contact DUDLEY HARRIS
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/16/1998
Decision Date 02/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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