FDA 510(k)

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform

K-Nummer: K202300 · 2021-03-05

Entscheidungsdatum2021-03-05

ProduktcodePOK

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform is the device name listed in this FDA 510(k) record. The listed applicant is Optellum, Ltd.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K202300. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Optellum Virtual Nodule Clinic, Optellum software, Optellum platform?

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Optellum, Ltd.. The 510(k) number is K202300.

When did Optellum Virtual Nodule Clinic, Optellum software, Optellum platform receive FDA 510(k) clearance?

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform received FDA 510(k) clearance on 2021-03-05, under 510(k) number K202300.

Who is the listed applicant for Optellum Virtual Nodule Clinic, Optellum software, Optellum platform?

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

What is the FDA product code for Optellum Virtual Nodule Clinic, Optellum software, Optellum platform?

The FDA product code for Optellum Virtual Nodule Clinic, Optellum software, Optellum platform is POK.

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