FDA 510(k)

AOK 95A 医疗口罩（20200049）

K号: K220876 · 2022-07-27

决定日期2022-07-27

产品代码FXX

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决定实质等同

器械摘要

AOK 95A Medical Mask (20200049) is the device name listed in this FDA 510(k) record. The listed applicant is Aok Tooling Limited. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K220876. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AOK 95A Medical Mask (20200049)?

AOK 95A Medical Mask (20200049) is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Aok Tooling Limited. The 510(k) number is K220876.

When did AOK 95A Medical Mask (20200049) receive FDA 510(k) clearance?

AOK 95A Medical Mask (20200049) received FDA 510(k) clearance on 2022-07-27, under 510(k) number K220876.

Who is the listed applicant for AOK 95A Medical Mask (20200049)?

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

What is the FDA product code for AOK 95A Medical Mask (20200049)?

The FDA product code for AOK 95A Medical Mask (20200049) is FXX.

列明Aok Tooling Limited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。

K211956039外科口罩 K201517普通外科口罩

相关器械（代码：FXX）

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。

K251967HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带；HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，带有 WrapAround 护目镜O&M Halyard, Inc.K252534Surgical Face Mask (耳挂式)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398一次性手术口罩（非无菌）(EFX3PLBLKMSK300)Efofex, Inc.K252830一次性外科口罩（3P00B，C2900）Beatles Medical Supplies (Xiantao) Co., Ltd.K252650一次性医用口罩Makrite Industries, Inc.K243342KP防护口罩Kp Trading Co., Ltd.

官方来源

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