FDA 510(k)

手術衣

K番号: K212812 · 2022-11-16

申請者Xianning Marveldas Protective Articles Co., Ltd.

決定日2022-11-16

製品コードFYA

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Xianning Marveldas Protective Articles Co., Ltd.. It received FDA 510(k) clearance on 2022-11-16 under 510(k) number K212812. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Surgical Gown?

Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-11-16. The listed applicant is Xianning Marveldas Protective Articles Co., Ltd.. The 510(k) number is K212812.

When did Surgical Gown receive FDA 510(k) clearance?

Surgical Gown received FDA 510(k) clearance on 2022-11-16, under 510(k) number K212812.

Who is the listed applicant for Surgical Gown?

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

What is the FDA product code for Surgical Gown?

The FDA product code for Surgical Gown is FYA.

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手術衣

医療機器の概要

よくある質問

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関連機器（コード：FYA）

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