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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K152139
FOIA Releasable 510(k) K152139
Device Name Vital Connect Platform, HealthPatch MD, VitalPatch
Applicant
Vitalconnect, Inc.
900 E. Hamilton Ave.
Suite 500
Campbell,  CA  95008
Applicant Contact BONNIE WU
Correspondent
Vitalconnect, Inc.
900 E. Hamilton Ave.
Suite 500
Campbell,  CA  95008
Correspondent Contact BONNIE WU
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DSI   MHX  
Date Received08/03/2015
Decision Date 12/06/2015
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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