FDA 510(k)

耳友好口罩

K号: K211105 · 2021-05-17

决定日期2021-05-17

产品代码FXX

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决定实质等同

器械摘要

Ear-Friendly Mask is the device name listed in this FDA 510(k) record. The listed applicant is Ray Co., Ltd.. It received FDA 510(k) clearance on 2021-05-17 under 510(k) number K211105. 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 Ear-Friendly Mask?

Ear-Friendly Mask is a medical device that received FDA 510(k) clearance on 2021-05-17. The listed applicant is Ray Co., Ltd.. The 510(k) number is K211105.

When did Ear-Friendly Mask receive FDA 510(k) clearance?

Ear-Friendly Mask received FDA 510(k) clearance on 2021-05-17, under 510(k) number K211105.

Who is the listed applicant for Ear-Friendly Mask?

The FDA 510(k) record lists Ray Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ear-Friendly Mask?

The FDA product code for Ear-Friendly Mask is FXX.

列明Ray Co., Ltd.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。

K260462RCT800 K251798RCT700 K251109SMARTDent K243903RCT600 K233625RAYDENT SW K232325RAYSCAN a-Expert

查看所有 17 个设备 →

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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