VV330 Continuous ECG Platform, VivaLNK Adhesive Patch

Transmitters And Receivers, Physiological Signal, Radiofrequency

VivaLNK, Inc.

The following data is part of a premarket notification filed by Vivalnk, Inc. with the FDA for Vv330 Continuous Ecg Platform, Vivalnk Adhesive Patch.

Pre-market Notification Details

Device IDK191870
510k NumberK191870
Device Name:VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant VivaLNK, Inc. 51 E. Campbell Ave. Suite 160 Campbell,  CA  95008
ContactQuoi V. Huynh
CorrespondentQuoi V. Huynh
VivaLNK, Inc. 51 E. Campbell Ave. Suite 160 Campbell,  CA  95008
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-12
Decision Date2020-01-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865064000157 K191870 000

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