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FDA 510(k)

非織布口罩(型號:VQN0185W(耳掛式)和VQN0185B(繫帶式))

K 號:K173062 · 2018-01-25

決定日期2018-01-25
產品代碼FXX
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

相關器械(代碼:FXX)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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