FDA 510(k)

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

Número K: K241366 · 2024-10-29

Data da decisão2024-10-29

Código do produtoCBP

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) is the device name listed in this FDA 510(k) record. The listed applicant is Dehas Medical Systems GmbH. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K241366. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Dehas Medical Systems GmbH. The 510(k) number is K241366.

When did QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) receive FDA 510(k) clearance?

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) received FDA 510(k) clearance on 2024-10-29, under 510(k) number K241366.

Who is the listed applicant for QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

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

What is the FDA product code for QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

The FDA product code for QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) is CBP.

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Fonte oficial

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