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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Outpatient Cardiac Telemetry
510(k) Number K020632
Device Name ENGUARD REMOTE PATIENT MONITOR
Applicant
Mennen Medical , Ltd.
Kiryat Weizmann Science Park
P.O. Box 102
Rehovot,  IL 76100
Applicant Contact EREZ NIMROD
Correspondent
Mennen Medical , Ltd.
Kiryat Weizmann Science Park
P.O. Box 102
Rehovot,  IL 76100
Correspondent Contact EREZ NIMROD
Regulation Number870.1025
Classification Product Code
QYX  
Subsequent Product Code
DSI  
Date Received02/27/2002
Decision Date 03/15/2002
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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