FDA 510(k)

disposable 医療手術マスク

K番号: K202323 · 2021-02-02

申請者Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd.

決定日2021-02-02

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

Disposable Medical Surgical Masks is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd.. It received FDA 510(k) clearance on 2021-02-02 under 510(k) number K202323. 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 Disposable Medical Surgical Masks?

Disposable Medical Surgical Masks is a medical device that received FDA 510(k) clearance on 2021-02-02. The listed applicant is Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd.. The 510(k) number is K202323.

When did Disposable Medical Surgical Masks receive FDA 510(k) clearance?

Disposable Medical Surgical Masks received FDA 510(k) clearance on 2021-02-02, under 510(k) number K202323.

Who is the listed applicant for Disposable Medical Surgical Masks?

The FDA 510(k) record lists Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Surgical Masks?

The FDA product code for Disposable Medical Surgical Masks is FXX.

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disposable 医療手術マスク

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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