FDA 510(k)

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

Número K: K162442 · 2016-12-12

RequerenteGri Medical & Electrical Technology Co., Ltd.

Data da decisão2016-12-12

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 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 2016-12-12 under 510(k) number K162442. 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 ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K162442.

When did ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 receive FDA 510(k) clearance?

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 received FDA 510(k) clearance on 2016-12-12, under 510(k) number K162442.

Who is the listed applicant for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

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 ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

The FDA product code for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is FYA.

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

K172445RoyalGuard Surgical Gown, i600, Breathable K163191ComfortGuard Surgical Gown, i600, Film Reinforced

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Fonte oficial

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