FDA 510(k)

Mistral-Air Warming Unit

Número K: K171234 · 2017-05-26

RequerenteThe Surgical Company International BV (As the 37company)

Data da decisão2017-05-26

Código do produtoDWJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mistral-Air Warming Unit is the device name listed in this FDA 510(k) record. The listed applicant is The Surgical Company International BV (As the 37company). It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K171234. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mistral-Air Warming Unit?

Mistral-Air Warming Unit is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is The Surgical Company International BV (As the 37company). The 510(k) number is K171234.

When did Mistral-Air Warming Unit receive FDA 510(k) clearance?

Mistral-Air Warming Unit received FDA 510(k) clearance on 2017-05-26, under 510(k) number K171234.

Who is the listed applicant for Mistral-Air Warming Unit?

The FDA 510(k) record lists The Surgical Company International BV (As the 37company) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mistral-Air Warming Unit?

The FDA product code for Mistral-Air Warming Unit is DWJ.

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Dispositivos Relacionados (Código: DWJ)

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life K260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbH K260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Sistema de Gestão de Temperatura Arctic Sun (Modelo 5000)Medivance, Inc.

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