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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 K212957
Device Name BioButton System
Applicant
Biolntellisense, Inc.
570 El Camino Real
Suite #200
Redwood City,  CA  94063
Applicant Contact Yusi Liu
Correspondent
Biolntellisense, Inc.
570 El Camino Real
Suite #200
Redwood City,  CA  94063
Correspondent Contact Yusi Liu
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Code
NDC  
Date Received09/16/2021
Decision Date 12/12/2022
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
Recalls CDRH Recalls
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