FDA 510(k)

Motex防雾手术面罩

K号: K201549 · 2020-08-26

决定日期2020-08-26

产品代码FXX

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决定实质等同

器械摘要

Motex Anti-Fog Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Modern Healthcare Corp.. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K201549. 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 Motex Anti-Fog Surgical Face Mask?

Motex Anti-Fog Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Modern Healthcare Corp.. The 510(k) number is K201549.

When did Motex Anti-Fog Surgical Face Mask receive FDA 510(k) clearance?

Motex Anti-Fog Surgical Face Mask received FDA 510(k) clearance on 2020-08-26, under 510(k) number K201549.

Who is the listed applicant for Motex Anti-Fog Surgical Face Mask?

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

What is the FDA product code for Motex Anti-Fog Surgical Face Mask?

The FDA product code for Motex Anti-Fog Surgical Face Mask is FXX.

列明Modern Healthcare Corp.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。

K191898无菌乳胶无粉手术手套

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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