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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 K111917
Device Name NUVANT, MOBILE CARDIAC TELEMETRY
Applicant
Corventis, Inc.
1410 Energy Park Dr.,
Suite 1
St. Paul,  MN  55108
Applicant Contact MICHELE CHIN-PURCELL
Correspondent
Corventis, Inc.
1410 Energy Park Dr.,
Suite 1
St. Paul,  MN  55108
Correspondent Contact MICHELE CHIN-PURCELL
Regulation Number870.1025
Classification Product Code
QYX  
Subsequent Product Code
MHX  
Date Received07/06/2011
Decision Date 08/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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