FDA 510(k)

disposable 医療手術用フェイスマスク

K番号: K203200 · 2021-06-16

申請者Guangdong Haiou Medical Apparatus Co., Ltd.

決定日2021-06-16

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 Mask is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Haiou Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2021-06-16 under 510(k) number K203200. 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 Mask?

Disposable Medical Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-06-16. The listed applicant is Guangdong Haiou Medical Apparatus Co., Ltd.. The 510(k) number is K203200.

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

Disposable Medical Surgical Face Mask received FDA 510(k) clearance on 2021-06-16, under 510(k) number K203200.

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

The FDA 510(k) record lists Guangdong Haiou Medical Apparatus 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 Mask?

The FDA product code for Disposable Medical Surgical Face Mask 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）

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