FDA 510(k)

非接触式额头体温计（型号UT306H & UT308H）

K号: K203747 · 2021-01-25

申请人Uni-Trend Technology (China) Co., Ltd.

决定日期2021-01-25

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 Forehead Thermometer (Models UT306H & UT308H) is the device name listed in this FDA 510(k) record. The listed applicant is Uni-Trend Technology (China) Co., Ltd.. It received FDA 510(k) clearance on 2021-01-25 under 510(k) number K203747. 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 Forehead Thermometer (Models UT306H & UT308H)?

Non-Contact Forehead Thermometer (Models UT306H & UT308H) is a medical device that received FDA 510(k) clearance on 2021-01-25. The listed applicant is Uni-Trend Technology (China) Co., Ltd.. The 510(k) number is K203747.

When did Non-Contact Forehead Thermometer (Models UT306H & UT308H) receive FDA 510(k) clearance?

Non-Contact Forehead Thermometer (Models UT306H & UT308H) received FDA 510(k) clearance on 2021-01-25, under 510(k) number K203747.

Who is the listed applicant for Non-Contact Forehead Thermometer (Models UT306H & UT308H)?

The FDA 510(k) record lists Uni-Trend Technology (China) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-Contact Forehead Thermometer (Models UT306H & UT308H)?

The FDA product code for Non-Contact Forehead Thermometer (Models UT306H & UT308H) is FLL.

列明Uni-Trend Technology (China) 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。

K203656非接触式额头体温计（UT30H）

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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