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)

DRSplus

K-Number: K213705 · 2021-12-21

ApplicantCentervue S.P.A.
Decision Date2021-12-21
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DRSplus is a medical device manufactured by Centervue S.P.A.. It received FDA 510(k) clearance on 2021-12-21 under approval number K213705. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRSplus?

DRSplus is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Centervue S.P.A.. The 510(k) number is K213705.

When was DRSplus approved by the FDA?

DRSplus received FDA 510(k) clearance on 2021-12-21, under approval number K213705.

What company makes DRSplus?

DRSplus is manufactured by Centervue S.P.A..

What is the FDA product code for DRSplus?

The FDA product code for DRSplus is MYC.

Other Devices by Centervue S.P.A.

K153181MAIA K180526EIDON FA K180293Retia 2 K192113DRSplus K211328EIDON FA, EIDON, EIDON AF, EIDON UWFL K234076iCare ALTIUS CW

View all 8 devices →

Related Devices (Code: MYC)

K153181MAIACentervue S.P.A. K180526EIDON FACentervue S.P.A. K180293Retia 2Centervue S.P.A. K192113DRSplusCentervue S.P.A. K211328EIDON FA, EIDON, EIDON AF, EIDON UWFLCentervue S.P.A. K241931OcuMet Beacon (OCUB100)Ocusciences, 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.

↑