FDA 510(k)

ProGear® 遮氧防護口罩，型號 AV82030

K 號：K231741 · 2024-09-05

決定日期2024-09-05

產品代碼OUK

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

ProGear® Surgical Mask with Oxafence®, Model AV82030 is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Ameritech. It received FDA 510(k) clearance on 2024-09-05 under 510(k) number K231741. The device is classified under product code OUK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ProGear® Surgical Mask with Oxafence®, Model AV82030?

ProGear® Surgical Mask with Oxafence®, Model AV82030 is a medical device that received FDA 510(k) clearance on 2024-09-05. The listed applicant is Prestige Ameritech. The 510(k) number is K231741.

When did ProGear® Surgical Mask with Oxafence®, Model AV82030 receive FDA 510(k) clearance?

ProGear® Surgical Mask with Oxafence®, Model AV82030 received FDA 510(k) clearance on 2024-09-05, under 510(k) number K231741.

Who is the listed applicant for ProGear® Surgical Mask with Oxafence®, Model AV82030?

The FDA 510(k) record lists Prestige Ameritech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProGear® Surgical Mask with Oxafence®, Model AV82030?

The FDA product code for ProGear® Surgical Mask with Oxafence®, Model AV82030 is OUK.

其他以 Prestige Ameritech 為申請人之記錄

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。

K171162外科耳環口罩配底部缺口護盾及外科緊身口罩配底部缺口護盾 K160100Prestige Ameritech 儿童口罩

相關器械（代碼：OUK）

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。

K192105Innonix 抗病毒兒童口罩Innonix Technologies Limited K182766Cufitec外科口罩Nbc Meshtec, Inc.

官方來源

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