FDA 510(k)

医療手術マスク（平面型）

K番号: K220824 · 2022-05-19

申請者Hunan Chopard Medical Devices Co., Ltd.

決定日2022-05-19

製品コードFXX

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

Medical Surgical Mask (Planar type) is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Chopard Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K220824. 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 Medical Surgical Mask (Planar type)?

Medical Surgical Mask (Planar type) is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Hunan Chopard Medical Devices Co., Ltd.. The 510(k) number is K220824.

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

Medical Surgical Mask (Planar type) received FDA 510(k) clearance on 2022-05-19, under 510(k) number K220824.

Who is the listed applicant for Medical Surgical Mask (Planar type)?

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

What is the FDA product code for Medical Surgical Mask (Planar type)?

The FDA product code for Medical Surgical Mask (Planar type) is FXX.

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医療手術マスク（平面型）

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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