FDA 510(k)

DRSplus

K-Number: K192113 · 2019-11-15

Decision Date2019-11-15

Product CodeMYC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

DRSplus is the device name listed in this FDA 510(k) record. The listed applicant is Centervue S.P.A.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K192113. 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 2019-11-15. The listed applicant is Centervue S.P.A.. The 510(k) number is K192113.

When did DRSplus receive FDA 510(k) clearance?

DRSplus received FDA 510(k) clearance on 2019-11-15, under 510(k) number K192113.

Who is the listed applicant for DRSplus?

The FDA 510(k) record lists Centervue S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRSplus?

The FDA product code for DRSplus is MYC.

Other records listing Centervue S.P.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243504MAIA (AHMACME001)K234076iCare ALTIUS CW K213705DRSplus K211328EIDON FA, EIDON, EIDON AF, EIDON UWFL K180526EIDON FA K180293Retia 2

View all 8 devices →

Related Devices (Code: MYC)

K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.K243504MAIA (AHMACME001)Centervue S.P.A.K213705DRSplusCentervue S.P.A.K211328EIDON FA, EIDON, EIDON AF, EIDON UWFLCentervue S.P.A.K180526EIDON FACentervue S.P.A.K180293Retia 2Centervue S.P.A.

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.