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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 K132447
FOIA Releasable 510(k) K132447
Device Name VITALCONNECT PLATFORM BY VITAL CONNECT INC.
Applicant
Vitalconnect, Inc.
900 E. Hamilton Ave.
Suite 500
Campbell,  CA  95008
Applicant Contact SAM MOSTAFAVI
Correspondent
Vitalconnect, Inc.
900 E. Hamilton Ave.
Suite 500
Campbell,  CA  95008
Correspondent Contact SAM MOSTAFAVI
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Code
DSI  
Date Received08/06/2013
Decision Date 04/03/2014
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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