FDA 510(k)

SafeAir combi (SFR-combi-US)

Número K: K223932 · 2023-04-26

Data da decisão2023-04-26

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SafeAir combi (SFR-combi-US) is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2023-04-26 under 510(k) number K223932. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SafeAir combi (SFR-combi-US)?

SafeAir combi (SFR-combi-US) is a medical device that received FDA 510(k) clearance on 2023-04-26. The listed applicant is Lina Medical Aps. The 510(k) number is K223932.

When did SafeAir combi (SFR-combi-US) receive FDA 510(k) clearance?

SafeAir combi (SFR-combi-US) received FDA 510(k) clearance on 2023-04-26, under 510(k) number K223932.

Who is the listed applicant for SafeAir combi (SFR-combi-US)?

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

What is the FDA product code for SafeAir combi (SFR-combi-US)?

The FDA product code for SafeAir combi (SFR-combi-US) is GEI.

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Outros registros que listam Lina Medical Aps como candidato(a)

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Fonte oficial

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