FDA 510(k)

ProGear® 氧化锌防护口罩，型号 AV82030

K号: K231741 · 2024-09-05

决定日期2024-09-05

产品代码OUK

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Prestige Ameritech为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield K160100Prestige Ameritech 儿科/儿童面罩

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。