FDA 510(k)

普通外科口罩

K号: K201517 · 2020-09-04

决定日期2020-09-04

产品代码FXX

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决定实质等同

器械摘要

Plain Surgical 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 2020-09-04 under 510(k) number K201517. 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 Plain Surgical Mask?

Plain Surgical Mask is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Aok Tooling Limited. The 510(k) number is K201517.

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

Plain Surgical Mask received FDA 510(k) clearance on 2020-09-04, under 510(k) number K201517.

Who is the listed applicant for Plain Surgical 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 Plain Surgical Mask?

The FDA product code for Plain Surgical 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）K211956039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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