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FDA 510(k)

非接触式红外体温计，型号：HTD8823US

K号: K200159 · 2021-01-05

申请人Hetaida Technology Co., Ltd.
决定日期2021-01-05
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 Infrared Body Thermometer, model:HTD8823US is the device name listed in this FDA 510(k) record. The listed applicant is Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-05 under 510(k) number K200159. 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 Infrared Body Thermometer, model:HTD8823US?

Non-contact Infrared Body Thermometer, model:HTD8823US is a medical device that received FDA 510(k) clearance on 2021-01-05. The listed applicant is Hetaida Technology Co., Ltd.. The 510(k) number is K200159.

When did Non-contact Infrared Body Thermometer, model:HTD8823US receive FDA 510(k) clearance?

Non-contact Infrared Body Thermometer, model:HTD8823US received FDA 510(k) clearance on 2021-01-05, under 510(k) number K200159.

Who is the listed applicant for Non-contact Infrared Body Thermometer, model:HTD8823US?

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

What is the FDA product code for Non-contact Infrared Body Thermometer, model:HTD8823US?

The FDA product code for Non-contact Infrared Body Thermometer, model:HTD8823US 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

列明Hetaida 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。

K243661电子血压计K241202电动鼻吸器（HTD2601US）K223170电子血压计，型号：HTD6602USK203332非接触式红外体温计，型号HTD8808C，HTD8818A，HTD8816CK180387红外耳温计K171888非接触式红外体温计

查看所有 8 个设备 →

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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