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FDA 510(k)

红外额温计（型号：T80，T81，T82，T83，T84，T85）

K号: K210014 · 2021-06-04

申请人Guandong Genial Technology Co., Limited
决定日期2021-06-04
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: T80, T81, T82, T83, T84, T85) is the device name listed in this FDA 510(k) record. The listed applicant is Guandong Genial Technology Co., Limited. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K210014. 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: T80, T81, T82, T83, T84, T85)?

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Guandong Genial Technology Co., Limited. The 510(k) number is K210014.

When did Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) receive FDA 510(k) clearance?

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) received FDA 510(k) clearance on 2021-06-04, under 510(k) number K210014.

Who is the listed applicant for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)?

The FDA 510(k) record lists Guandong Genial Technology Co., Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)?

The FDA product code for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) is FLL.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K253162温度探头 (T2252-PG)；温度探头 (TCMA-AG)；温度探头 (TCMA-PG)；温度探头 (TMQ-DAG)；温度探头 (THP-DAG)Unimed Medical Supplies, Inc.K251160无菌温度探头（型号：W0001ES，W0028ES，W0101FS-A，W0101FS-P，W0099LS，W0099FS，W0099PS）Shenzhen Med-Link Electronics Tech Co., Ltd.K250470耳温计（EAR-E101）；耳温计（EAR-E102）；耳温计（EAR-E103）Shenzhen AOJ Medical Technology Co., Ltd.K243000可重复使用温度探头（T1306, T2306, T3306, T4306）；一次性温度探头（T5106, T6106）Shenzhen Medke Technology Co., Ltd.K250878优威尔® 红外耳温枪（YHT100）；优威尔® 红外耳温枪（YHT107）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082红外体温计Guangzhou Daxin Health Technology Co., Ltd.

官方来源

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