FDA 510(k)

disposable medical mask

K番号: K202137 · 2021-03-04

決定日2021-03-04

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 mask is the device name listed in this FDA 510(k) record. The listed applicant is U-Play Products Corporation. It received FDA 510(k) clearance on 2021-03-04 under 510(k) number K202137. 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 mask?

Disposable medical mask is a medical device that received FDA 510(k) clearance on 2021-03-04. The listed applicant is U-Play Products Corporation. The 510(k) number is K202137.

When did Disposable medical mask receive FDA 510(k) clearance?

Disposable medical mask received FDA 510(k) clearance on 2021-03-04, under 510(k) number K202137.

Who is the listed applicant for Disposable medical mask?

The FDA 510(k) record lists U-Play Products Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable medical mask?

The FDA product code for Disposable medical mask is FXX.

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disposable medical 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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