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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K030656
Device Name ENVAN HEART RATE MONITOR
Applicant
Envan, LLC
719 A St. NE
Washington,  DC  20002
Applicant Contact MARIE MARLOW
Correspondent
Envan, LLC
719 A St. NE
Washington,  DC  20002
Correspondent Contact MARIE MARLOW
Regulation Number870.2300
Classification Product Code
DRT  
Date Received03/03/2003
Decision Date 04/08/2003
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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