FDA 510(k)

VV330 Continuous ECG Platform, VivaLNK Adhesive Patch

K-Number: K191870 · 2020-01-07

Decision Date2020-01-07

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VV330 Continuous ECG Platform, VivaLNK Adhesive Patch is a medical device manufactured by VivaLNK, Inc.. It received FDA 510(k) clearance on 2020-01-07 under approval number K191870. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VV330 Continuous ECG Platform, VivaLNK Adhesive Patch?

VV330 Continuous ECG Platform, VivaLNK Adhesive Patch is a medical device that received FDA 510(k) clearance on 2020-01-07. It is manufactured by VivaLNK, Inc.. The 510(k) number is K191870.

When was VV330 Continuous ECG Platform, VivaLNK Adhesive Patch approved by the FDA?

VV330 Continuous ECG Platform, VivaLNK Adhesive Patch received FDA 510(k) clearance on 2020-01-07, under approval number K191870.

What company makes VV330 Continuous ECG Platform, VivaLNK Adhesive Patch?

VV330 Continuous ECG Platform, VivaLNK Adhesive Patch is manufactured by VivaLNK, Inc..

What is the FDA product code for VV330 Continuous ECG Platform, VivaLNK Adhesive Patch?

The FDA product code for VV330 Continuous ECG Platform, VivaLNK Adhesive Patch is DRG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.