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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 K172011
Device Name LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)
HMicro, Inc.
39355 California Street, #303
Fremont,  CA  94538
Applicant Contact Kim Tompkins
LifeSignals, Inc.
39355 California Street, Suite 305
Fremont,  CA  94538
Correspondent Contact Saravanan Balasubramanlan
Regulation Number870.2910
Classification Product Code
Subsequent Product Codes
Date Received07/03/2017
Decision Date 06/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No