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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 K023798
Device Name MODIFICATION TO ENVOY PATIENT MONITOR
Applicant
Mennen Medical , Ltd.
4 Hayarden St., Yavne
P.O. Box 102
Rohovot,  IL 76100
Applicant Contact EREZ NIMROD
Correspondent
Mennen Medical , Ltd.
4 Hayarden St., Yavne
P.O. Box 102
Rohovot,  IL 76100
Correspondent Contact EREZ NIMROD
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/14/2002
Decision Date 12/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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