FDA 510(k)

RightEye Vision System

Numéro K : K181771 · 2018-09-28

Date de décision2018-09-28

Code produitGWN

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

RightEye Vision System is the device name listed in this FDA 510(k) record. The listed applicant is Righteye, LLC. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K181771. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the RightEye Vision System?

RightEye Vision System is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Righteye, LLC. The 510(k) number is K181771.

When did RightEye Vision System receive FDA 510(k) clearance?

RightEye Vision System received FDA 510(k) clearance on 2018-09-28, under 510(k) number K181771.

Who is the listed applicant for RightEye Vision System?

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

What is the FDA product code for RightEye Vision System?

The FDA product code for RightEye Vision System is GWN.

Essais cliniques associés

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Source officielle

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