FDA 510(k)

disposable 医療手術用フェイスマスク

K番号: K202211 · 2020-12-22

決定日2020-12-22

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 Face Masks is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kaidi Garments Co.,Ltd. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K202211. 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 Face Masks?

Disposable Medical Surgical Face Masks is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Guangdong Kaidi Garments Co.,Ltd. The 510(k) number is K202211.

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

Disposable Medical Surgical Face Masks received FDA 510(k) clearance on 2020-12-22, under 510(k) number K202211.

Who is the listed applicant for Disposable Medical Surgical Face Masks?

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

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

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

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disposable 医療手術用フェイスマスク

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）

公式ソース