FDA 510(k)

EVA NEXUS Ophthalmic Surgical System

Numéro K : K213467 · 2022-06-14

DemandeurD.O.R.C. Dutch Ophthalmic Research Center (International)

Date de décision2022-06-14

Code produitHQC

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

EVA NEXUS Ophthalmic Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is D.O.R.C. Dutch Ophthalmic Research Center (International). It received FDA 510(k) clearance on 2022-06-14 under 510(k) number K213467. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the EVA NEXUS Ophthalmic Surgical System?

EVA NEXUS Ophthalmic Surgical System is a medical device that received FDA 510(k) clearance on 2022-06-14. The listed applicant is D.O.R.C. Dutch Ophthalmic Research Center (International). The 510(k) number is K213467.

When did EVA NEXUS Ophthalmic Surgical System receive FDA 510(k) clearance?

EVA NEXUS Ophthalmic Surgical System received FDA 510(k) clearance on 2022-06-14, under 510(k) number K213467.

Who is the listed applicant for EVA NEXUS Ophthalmic Surgical System?

The FDA 510(k) record lists D.O.R.C. Dutch Ophthalmic Research Center (International) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVA NEXUS Ophthalmic Surgical System?

The FDA product code for EVA NEXUS Ophthalmic Surgical System is HQC.

Essais cliniques associés

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Autres dossiers indiquant D.O.R.C. Dutch Ophthalmic Research Center (International) en tant que demandeur

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Dispositifs connexes (Code : HQC)

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Source officielle

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