FDA 510(k)

Adaptador de Nebulizador Airvo

Número K: K211560 · 2021-12-10

RequerenteFisher & Paykel Healthcare Limited

Data da decisão2021-12-10

Código do produtoCAF

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Airvo Nebulizer Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K211560. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Airvo Nebulizer Adapter?

Airvo Nebulizer Adapter is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Fisher & Paykel Healthcare Limited. The 510(k) number is K211560.

When did Airvo Nebulizer Adapter receive FDA 510(k) clearance?

Airvo Nebulizer Adapter received FDA 510(k) clearance on 2021-12-10, under 510(k) number K211560.

Who is the listed applicant for Airvo Nebulizer Adapter?

The FDA 510(k) record lists Fisher & Paykel Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Airvo Nebulizer Adapter?

The FDA product code for Airvo Nebulizer Adapter is CAF.

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Fonte oficial

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