FDA 510(k)

Lifemotion Disposable Membrane Oxygenator

Número K: K253838 · 2026-03-16

RequerenteLifemotion Medical Technology Co., Ltd.

Data da decisão2026-03-16

Código do produtoDTZ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lifemotion Disposable Membrane Oxygenator is the device name listed in this FDA 510(k) record. The listed applicant is Lifemotion Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K253838. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lifemotion Disposable Membrane Oxygenator?

Lifemotion Disposable Membrane Oxygenator is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Lifemotion Medical Technology Co., Ltd.. The 510(k) number is K253838.

When did Lifemotion Disposable Membrane Oxygenator receive FDA 510(k) clearance?

Lifemotion Disposable Membrane Oxygenator received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253838.

Who is the listed applicant for Lifemotion Disposable Membrane Oxygenator?

The FDA 510(k) record lists Lifemotion Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lifemotion Disposable Membrane Oxygenator?

The FDA product code for Lifemotion Disposable Membrane Oxygenator is DTZ.

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