FDA 510(k)

医療用フェイスマスク

K番号: K212994 · 2022-01-17

申請者Guangzhou Quantum Laser Intelligent Equipment Co., Ltd.

決定日2022-01-17

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

Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Quantum Laser Intelligent Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-01-17 under 510(k) number K212994. 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 Medical Face Mask?

Medical Face Mask is a medical device that received FDA 510(k) clearance on 2022-01-17. The listed applicant is Guangzhou Quantum Laser Intelligent Equipment Co., Ltd.. The 510(k) number is K212994.

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

Medical Face Mask received FDA 510(k) clearance on 2022-01-17, under 510(k) number K212994.

Who is the listed applicant for Medical Face Mask?

The FDA 510(k) record lists Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Face Mask?

The FDA product code for Medical Face Mask is FXX.

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医療用フェイスマスク

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）

公式ソース