FDA 510(k)

非接触式额温计

K号: K161735 · 2016-11-17

申请人Shenzhen Dongdixin Technology Co., Ltd.

决定日期2016-11-17

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 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K161735. 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?

Non-contact Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K161735.

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

Non-contact Forehead Thermometer received FDA 510(k) clearance on 2016-11-17, under 510(k) number K161735.

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

The FDA 510(k) record lists Shenzhen Dongdixin Technology 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?

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

列明Shenzhen Dongdixin 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。

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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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