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FDA 510(k)

VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20

K-Number: K192757 · 2020-02-06

ApplicantVitalconnect, Inc.
Decision Date2020-02-06
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 is a medical device manufactured by Vitalconnect, Inc.. It received FDA 510(k) clearance on 2020-02-06 under approval number K192757. 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 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20?

VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 is a medical device that received FDA 510(k) clearance on 2020-02-06. It is manufactured by Vitalconnect, Inc.. The 510(k) number is K192757.

When was VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 approved by the FDA?

VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 received FDA 510(k) clearance on 2020-02-06, under approval number K192757.

What company makes VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20?

VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 is manufactured by Vitalconnect, Inc..

What is the FDA product code for VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20?

The FDA product code for VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 is DRG.

Other Devices by Vitalconnect, Inc.

K163453VitalPatch® VitalConnect Platform 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) K242129VitalRhythm

View all 7 devices →

Related Devices (Code: DRG)

K161916TelePatch Cardiac MonitorMedicomp, Inc. K153719LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStreamHoneywell Hommed, LLC K163694Rooti Rx ECG Event Recorder, Rooti Link APP SoftwareRooti Labs , Ltd. K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc. K171406Optum TeleHealth ApplicationUnited Health Group, Inc. K171029eCareCoordinatorVisicu, Inc.

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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