FDA 510(k)

非接触式电子额温计

K号: K201582 · 2021-01-15

申请人Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.

决定日期2021-01-15

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

Non-contact Electronic Forehead Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K201582. 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 Non-contact Electronic Forehead Infrared Thermometer?

Non-contact Electronic Forehead Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.. The 510(k) number is K201582.

When did Non-contact Electronic Forehead Infrared Thermometer receive FDA 510(k) clearance?

Non-contact Electronic Forehead Infrared Thermometer received FDA 510(k) clearance on 2021-01-15, under 510(k) number K201582.

Who is the listed applicant for Non-contact Electronic Forehead Infrared Thermometer?

The FDA 510(k) record lists Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-contact Electronic Forehead Infrared Thermometer?

The FDA product code for Non-contact Electronic Forehead Infrared Thermometer is FLL.

列明Zhongshan Jinli Electronic Weighing Equipment 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。

K231116多参数探测器

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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