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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 K202868
Device Name LifeSignals Multi-Parameter Remote Monitoring Platform
Applicant
Lifesignals, Inc.
39355 California St., Suite 305
Fremont,  CA  94538
Applicant Contact Saravanan Balasubramanian
Correspondent
MethodSense, Inc.
One Copley Pkwy.
Suite 410
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
FLL   MHX  
Date Received09/28/2020
Decision Date 07/21/2021
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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