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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 K141167
Device Name VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
Applicant
VITAL CONNECT INC.
900 E. HAMILTON AVE.,
SUITE 500
CAMPBELL,  CA  95008
Applicant Contact SAM MOSTAFAVI
Correspondent
VITAL CONNECT INC.
900 E. HAMILTON AVE.,
SUITE 500
CAMPBELL,  CA  95008
Correspondent Contact SAM MOSTAFAVI
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DSI   MHX  
Date Received05/06/2014
Decision Date 07/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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