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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K201302
Device Name LiveOne
Applicant
Livemetric (Medical) S.A.
40 Rue Glesener
Luxemburg,  LU L-1630
Applicant Contact Chen Botvin Moshe
Correspondent
Livemetric (Medical) S.A.
40 Rue Glesener
Luxemburg,  LU L-1630
Correspondent Contact Chen Botvin Moshe
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/15/2020
Decision Date 05/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT03919136
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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