FDA 510(k)

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)

Número K: K242769 · 2025-04-04

Data da decisão2025-04-04

Código do produtoBTL

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K242769. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K242769.

When did VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) receive FDA 510(k) clearance?

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242769.

Who is the listed applicant for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

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

What is the FDA product code for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

The FDA product code for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is BTL.

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Outros registros que listam Draegerwerk AG & CO Kgaa como candidato(a)

K253647Evita (V800); Evita (V600)K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)K222024Evita V800, Evita V600 K222207Babylog VN800, Babylog VN600 K221118CO2 Mainstream Sensor K162821Babyleo TN500

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Fonte oficial

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