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FDA 510(k)

VitalPatch® VitalConnect Platform

K-Number: K163453 · 2017-11-02

ApplicantVitalconnect, Inc.
Decision Date2017-11-02
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitalPatch® VitalConnect Platform is a medical device manufactured by Vitalconnect, Inc.. It received FDA 510(k) clearance on 2017-11-02 under approval number K163453. 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 VitalPatch® VitalConnect Platform?

VitalPatch® VitalConnect Platform is a medical device that received FDA 510(k) clearance on 2017-11-02. It is manufactured by Vitalconnect, Inc.. The 510(k) number is K163453.

When was VitalPatch® VitalConnect Platform approved by the FDA?

VitalPatch® VitalConnect Platform received FDA 510(k) clearance on 2017-11-02, under approval number K163453.

What company makes VitalPatch® VitalConnect Platform?

VitalPatch® VitalConnect Platform is manufactured by Vitalconnect, Inc..

What is the FDA product code for VitalPatch® VitalConnect Platform?

The FDA product code for VitalPatch® VitalConnect Platform is DRG.

Other Devices by Vitalconnect, Inc.

K170973VitalWatch Software User Interface K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 K183078VitalConnect Platform, VitalPatch Biosensor K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 K242129VitalRhythm

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Official Source

View on FDA Database →

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

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