FDA 510(k)

ROKI Surgical Mask

Número K: K214094 · 2022-02-24

Data da decisão2022-02-24

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ROKI Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Roki Co., Ltd.. It received FDA 510(k) clearance on 2022-02-24 under 510(k) number K214094. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ROKI Surgical Mask?

ROKI Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is Roki Co., Ltd.. The 510(k) number is K214094.

When did ROKI Surgical Mask receive FDA 510(k) clearance?

ROKI Surgical Mask received FDA 510(k) clearance on 2022-02-24, under 510(k) number K214094.

Who is the listed applicant for ROKI Surgical Mask?

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

What is the FDA product code for ROKI Surgical Mask?

The FDA product code for ROKI Surgical Mask is FXX.

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