FDA 510(k)

RT Elements (4.0)

Número K: K223279 · 2023-03-14

Data da decisão2023-03-14

Código do produtoMUJ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

RT Elements (4.0) is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2023-03-14 under 510(k) number K223279. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RT Elements (4.0)?

RT Elements (4.0) is a medical device that received FDA 510(k) clearance on 2023-03-14. The listed applicant is Brainlab AG. The 510(k) number is K223279.

When did RT Elements (4.0) receive FDA 510(k) clearance?

RT Elements (4.0) received FDA 510(k) clearance on 2023-03-14, under 510(k) number K223279.

Who is the listed applicant for RT Elements (4.0)?

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

What is the FDA product code for RT Elements (4.0)?

The FDA product code for RT Elements (4.0) is MUJ.

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Outros registros que listam Brainlab AG como candidato(a)

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Fonte oficial

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