LifeSignals ECG Remote Monitoring Patch Platform

Transmitters And Receivers, Physiological Signal, Radiofrequency

LifeSignals, Inc.

The following data is part of a premarket notification filed by Lifesignals, Inc. with the FDA for Lifesignals Ecg Remote Monitoring Patch Platform.

Pre-market Notification Details

Device IDK200690
510k NumberK200690
Device Name:LifeSignals ECG Remote Monitoring Patch Platform
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant LifeSignals, Inc. 39355 California Street, Suite 305 Fremont,  CA  94538
ContactSaravanan Balasubramanian
CorrespondentSaravanan Balasubramanian
LifeSignals, Inc. 39355 California Street, Suite 305 Fremont,  CA  94538
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-16
Decision Date2020-07-15

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