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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 K190916
Device Name VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
Applicant
VitalConnect, Inc.
224 Airport Parkway, Suite 300
San Jose,  CA  95110
Applicant Contact Cynthia Merrell
Correspondent
VitalConnect, Inc.
224 Airport Parkway, Suite 300
San Jose,  CA  95110
Correspondent Contact Cynthia Merrell
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DSI   MHX  
Date Received04/09/2019
Decision Date 06/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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