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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K222017
Device Name Biotres
Applicant
Biotricity
203 Redwood Shores Pkwy
Suite 600
Redwood City,  CA  94065
Applicant Contact Spencer LaDow
Correspondent
Biotricity
203 Redwood Shores Pkwy
Suite 600
Redwood City,  CA  94065
Correspondent Contact Spencer LaDow
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received07/08/2022
Decision Date 07/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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