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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K030722
Device Name ENVOY PATIENT MONITOR
Applicant
Mennen Medical, Inc.
P.O. Box 102
Rehovot,  IL 76100
Applicant Contact ASHER KASSEL
Correspondent
Mennen Medical, Inc.
P.O. Box 102
Rehovot,  IL 76100
Correspondent Contact ASHER KASSEL
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Code
BZK  
Date Received03/07/2003
Decision Date 02/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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