FDA 510(k)

RoyalGuard Surgical Gown, i600, Breathable

Número K: K172445 · 2017-12-08

RequerenteGri Medical & Electrical Technology Co., Ltd.

Data da decisão2017-12-08

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RoyalGuard Surgical Gown, i600, Breathable is the device name listed in this FDA 510(k) record. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-12-08 under 510(k) number K172445. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RoyalGuard Surgical Gown, i600, Breathable?

RoyalGuard Surgical Gown, i600, Breathable is a medical device that received FDA 510(k) clearance on 2017-12-08. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K172445.

When did RoyalGuard Surgical Gown, i600, Breathable receive FDA 510(k) clearance?

RoyalGuard Surgical Gown, i600, Breathable received FDA 510(k) clearance on 2017-12-08, under 510(k) number K172445.

Who is the listed applicant for RoyalGuard Surgical Gown, i600, Breathable?

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

What is the FDA product code for RoyalGuard Surgical Gown, i600, Breathable?

The FDA product code for RoyalGuard Surgical Gown, i600, Breathable is FYA.

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Outros registros que listam Gri Medical & Electrical Technology Co., Ltd. como candidato(a)

K163191ComfortGuard Surgical Gown, i600, Film Reinforced K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

Dispositivos Relacionados (Código: FYA)

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Fonte oficial

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