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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 K191614
Device Name BioSticker System
Applicant
Biointellisense, Inc.
570 El Camino Real
Suite #200
Redwood City,  CA  94063
Applicant Contact Henry Leung
Correspondent
Biointellisense, Inc.
570 El Camino Real
Suite #200
Redwood City,  CA  94063
Correspondent Contact Henry Leung
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Code
NDC  
Date Received06/18/2019
Decision Date 12/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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