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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 K924672
Device Name ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY)
Applicant
AGILENT TECHNOLOGIES
20 NORTH AVIADOR ST.
CAMARILLO,  CA  93010
Applicant Contact JOSE R GONZALEZ
Correspondent
AGILENT TECHNOLOGIES
20 NORTH AVIADOR ST.
CAMARILLO,  CA  93010
Correspondent Contact JOSE R GONZALEZ
Regulation Number870.1025
Classification Product Code
DSI  
Date Received09/16/1992
Decision Date 12/15/1992
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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