FDA 510(k)

使い捨て手術用耳ひも付顔マスク

K番号: K211042 · 2021-07-15

決定日2021-07-15

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 Procedural Ear-loop Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Dsb Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-07-15 under 510(k) number K211042. 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 Procedural Ear-loop Face Mask?

Disposable Procedural Ear-loop Face Mask is a medical device that received FDA 510(k) clearance on 2021-07-15. The listed applicant is Changzhou Dsb Medical Co., Ltd.. The 510(k) number is K211042.

When did Disposable Procedural Ear-loop Face Mask receive FDA 510(k) clearance?

Disposable Procedural Ear-loop Face Mask received FDA 510(k) clearance on 2021-07-15, under 510(k) number K211042.

Who is the listed applicant for Disposable Procedural Ear-loop Face Mask?

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

What is the FDA product code for Disposable Procedural Ear-loop Face Mask?

The FDA product code for Disposable Procedural Ear-loop Face Mask is FXX.

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使い捨て手術用耳ひも付顔マスク

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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