FDA 510(k)

N9+

Número K: K223785 · 2023-04-14

Data da decisão2023-04-14

Código do produtoDQD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

N9+ is the device name listed in this FDA 510(k) record. The listed applicant is Nonagon , Ltd.. It received FDA 510(k) clearance on 2023-04-14 under 510(k) number K223785. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the N9+?

N9+ is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is Nonagon , Ltd.. The 510(k) number is K223785.

When did N9+ receive FDA 510(k) clearance?

N9+ received FDA 510(k) clearance on 2023-04-14, under 510(k) number K223785.

Who is the listed applicant for N9+?

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

What is the FDA product code for N9+?

The FDA product code for N9+ is DQD.

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