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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 K183078
Device Name VitalConnect Platform, VitalPatch Biosensor
Applicant
Vitalconnect, Inc.
224 Airport Pkwy., Suite 300
San Jose,  CA  95110
Applicant Contact Cynthia Merrell
Correspondent
Medical Device Academy, Inc.
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Robert Packard
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DSI   MHX  
Date Received11/05/2018
Decision Date 03/07/2019
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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