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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 K241101
Device Name BioButton System
Applicant
Biointellisense, Inc.
570 El Camino Real
Suite #200
Redwood City,  CA  94063
Applicant Contact Yusi Liu
Correspondent
Biointellisense, 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
DRT  
Date Received04/22/2024
Decision Date 09/26/2024
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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