FDA 510(k)

VitreOx Anti-fog Solution

Numéro K : K163257 · 2017-05-24

Date de décision2017-05-24

Code produitOCT

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

VitreOx Anti-fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Sio2 Nanotech, LLC. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K163257. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the VitreOx Anti-fog Solution?

VitreOx Anti-fog Solution is a medical device that received FDA 510(k) clearance on 2017-05-24. The listed applicant is Sio2 Nanotech, LLC. The 510(k) number is K163257.

When did VitreOx Anti-fog Solution receive FDA 510(k) clearance?

VitreOx Anti-fog Solution received FDA 510(k) clearance on 2017-05-24, under 510(k) number K163257.

Who is the listed applicant for VitreOx Anti-fog Solution?

The FDA 510(k) record lists Sio2 Nanotech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitreOx Anti-fog Solution?

The FDA product code for VitreOx Anti-fog Solution is OCT.

Essais cliniques associés

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Dispositifs connexes (Code : OCT)

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Source officielle

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