FDA 510(k)

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

Número K: K222822 · 2023-06-14

Data da decisão2023-06-14

Código do produtoBZE

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) 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 2023-06-14 under 510(k) number K222822. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)?

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) is a medical device that received FDA 510(k) clearance on 2023-06-14. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K222822.

When did VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) receive FDA 510(k) clearance?

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) received FDA 510(k) clearance on 2023-06-14, under 510(k) number K222822.

Who is the listed applicant for VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)?

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 Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)?

The FDA product code for VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) is BZE.

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

K253647Evita (V800); Evita (V600)K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)K222024Evita V800, Evita V600 K222207Babylog VN800, Babylog VN600 K221118CO2 Mainstream Sensor K162821Babyleo TN500

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Fonte oficial

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