Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VitalConnect Platform, VitalPatch Biosensor

K-Number: K183078 · 2019-03-07

Decision Date2019-03-07
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitalConnect Platform, VitalPatch Biosensor is a medical device manufactured by Vitalconnect, Inc.. It received FDA 510(k) clearance on 2019-03-07 under approval number K183078. 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 VitalConnect Platform, VitalPatch Biosensor?

VitalConnect Platform, VitalPatch Biosensor is a medical device that received FDA 510(k) clearance on 2019-03-07. It is manufactured by Vitalconnect, Inc.. The 510(k) number is K183078.

When was VitalConnect Platform, VitalPatch Biosensor approved by the FDA?

VitalConnect Platform, VitalPatch Biosensor received FDA 510(k) clearance on 2019-03-07, under approval number K183078.

What company makes VitalConnect Platform, VitalPatch Biosensor?

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

What is the FDA product code for VitalConnect Platform, VitalPatch Biosensor?

The FDA product code for VitalConnect Platform, VitalPatch Biosensor is DRG.

Related Clinical Trials

Other Devices by Vitalconnect, Inc.

View all 7 devices →

Related Devices (Code: DRG)

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.