FDA 510(k)

Surgical Mask

K番号: K222335 · 2022-10-11

決定日2022-10-11

製品コードFXX

諮問委員会SU

決定Substantially Equivalent

医療機器の概要

Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Luoyang Sunmed Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-10-11 under 510(k) number K222335. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Surgical Mask?

Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-10-11. The listed applicant is Luoyang Sunmed Devices Co., Ltd.. The 510(k) number is K222335.

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

Surgical Mask received FDA 510(k) clearance on 2022-10-11, under 510(k) number K222335.

Who is the listed applicant for Surgical Mask?

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

What is the FDA product code for Surgical Mask?

The FDA product code for Surgical Mask is FXX.

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Surgical Mask

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FXX）

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