FDA 510(k)

VibrantVue Scleral Saline

Número K: K201069 · 2020-07-31

Data da decisão2020-07-31

Código do produtoMRC

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

VibrantVue Scleral Saline is the device name listed in this FDA 510(k) record. The listed applicant is Dry Eye Innovations, LLC. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K201069. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VibrantVue Scleral Saline?

VibrantVue Scleral Saline is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Dry Eye Innovations, LLC. The 510(k) number is K201069.

When did VibrantVue Scleral Saline receive FDA 510(k) clearance?

VibrantVue Scleral Saline received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201069.

Who is the listed applicant for VibrantVue Scleral Saline?

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

What is the FDA product code for VibrantVue Scleral Saline?

The FDA product code for VibrantVue Scleral Saline is MRC.

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Fonte oficial

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