FDA 510(k)

3層 disposable 医療マスク

K番号: K223045 · 2022-12-07

決定日2022-12-07

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

3-Ply Disposable Medical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wealth Lead Industrial Limited. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K223045. 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 3-Ply Disposable Medical Mask?

3-Ply Disposable Medical Mask is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Wealth Lead Industrial Limited. The 510(k) number is K223045.

When did 3-Ply Disposable Medical Mask receive FDA 510(k) clearance?

3-Ply Disposable Medical Mask received FDA 510(k) clearance on 2022-12-07, under 510(k) number K223045.

Who is the listed applicant for 3-Ply Disposable Medical Mask?

The FDA 510(k) record lists Wealth Lead Industrial Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3-Ply Disposable Medical Mask?

The FDA product code for 3-Ply Disposable Medical Mask is FXX.

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3層 disposable 医療マスク

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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