FDA 510(k)

非織布マスク（モデル：VQN0185W（耳掛け型）およびVQN0185B（紐付き））

K番号: K173062 · 2018-01-25

決定日2018-01-25

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

Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is the device name listed in this FDA 510(k) record. The listed applicant is V&Q Manufacturing Corporation. It received FDA 510(k) clearance on 2018-01-25 under 510(k) number K173062. 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 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))?

Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is V&Q Manufacturing Corporation. The 510(k) number is K173062.

When did Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) receive FDA 510(k) clearance?

Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) received FDA 510(k) clearance on 2018-01-25, under 510(k) number K173062.

Who is the listed applicant for Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))?

The FDA 510(k) record lists V&Q Manufacturing Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))?

The FDA product code for Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is FXX.

公式ソース

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非織布マスク（モデル：VQN0185W（耳掛け型）およびVQN0185B（紐付き））

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