FDA 510(k)

039外科口罩

K号: K211956 · 2021-11-23

决定日期2021-11-23

产品代码FXX

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决定实质等同

器械摘要

039 Surgical Face Mask 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 2021-11-23 under 510(k) number K211956. 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 039 Surgical Face Mask?

039 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Aok Tooling Limited. The 510(k) number is K211956.

When did 039 Surgical Face Mask receive FDA 510(k) clearance?

039 Surgical Face Mask received FDA 510(k) clearance on 2021-11-23, under 510(k) number K211956.

Who is the listed applicant for 039 Surgical Face Mask?

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 039 Surgical Face Mask?

The FDA product code for 039 Surgical Face Mask 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。

K220876AOK 95A 医疗口罩（20200049）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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