FDA 510(k)

红外额温计（型号IR-FT）

K号: K191668 · 2019-10-18

申请人Comper Chuangxiang (Beijing) Technology Co., Ltd.

决定日期2019-10-18

产品代码FLL

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Infrared Forehead Thermometer (Model IR-FT) is the device name listed in this FDA 510(k) record. The listed applicant is Comper Chuangxiang (Beijing) Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K191668. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Infrared Forehead Thermometer (Model IR-FT)?

Infrared Forehead Thermometer (Model IR-FT) is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Comper Chuangxiang (Beijing) Technology Co., Ltd.. The 510(k) number is K191668.

When did Infrared Forehead Thermometer (Model IR-FT) receive FDA 510(k) clearance?

Infrared Forehead Thermometer (Model IR-FT) received FDA 510(k) clearance on 2019-10-18, under 510(k) number K191668.

Who is the listed applicant for Infrared Forehead Thermometer (Model IR-FT)?

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

What is the FDA product code for Infrared Forehead Thermometer (Model IR-FT)?

The FDA product code for Infrared Forehead Thermometer (Model IR-FT) is FLL.

列明Comper Chuangxiang (Beijing) Technology 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。

K202481ThermArt (型号 IR-EFT)

相关器械（代码：FLL）

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。

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官方来源

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