FDA 510(k)

Orbit Subretinal Delivery System

Número K: K200325 · 2020-07-14

Data da decisão2020-07-14

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Orbit Subretinal Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Orbit Biomedical. It received FDA 510(k) clearance on 2020-07-14 under 510(k) number K200325. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Orbit Subretinal Delivery System?

Orbit Subretinal Delivery System is a medical device that received FDA 510(k) clearance on 2020-07-14. The listed applicant is Orbit Biomedical. The 510(k) number is K200325.

When did Orbit Subretinal Delivery System receive FDA 510(k) clearance?

Orbit Subretinal Delivery System received FDA 510(k) clearance on 2020-07-14, under 510(k) number K200325.

Who is the listed applicant for Orbit Subretinal Delivery System?

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

What is the FDA product code for Orbit Subretinal Delivery System?

The FDA product code for Orbit Subretinal Delivery System is FMF.

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