FDA 510(k)

disposable medical face mask - model FM-04

K番号: K202513 · 2021-04-09

決定日2021-04-09

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 Face Mask-Model FM-04 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jinko Industrial Co., Ltd.. It received FDA 510(k) clearance on 2021-04-09 under 510(k) number K202513. 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 Face Mask-Model FM-04?

Disposable Medical Face Mask-Model FM-04 is a medical device that received FDA 510(k) clearance on 2021-04-09. The listed applicant is Shenzhen Jinko Industrial Co., Ltd.. The 510(k) number is K202513.

When did Disposable Medical Face Mask-Model FM-04 receive FDA 510(k) clearance?

Disposable Medical Face Mask-Model FM-04 received FDA 510(k) clearance on 2021-04-09, under 510(k) number K202513.

Who is the listed applicant for Disposable Medical Face Mask-Model FM-04?

The FDA 510(k) record lists Shenzhen Jinko Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Face Mask-Model FM-04?

The FDA product code for Disposable Medical Face Mask-Model FM-04 is FXX.

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disposable medical face mask - model FM-04

医療機器の概要

よくある質問

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