FDA 510(k)

优威尔红外体温计

K号: K201864 · 2020-12-07

申请人Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

决定日期2020-12-07

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

YUWELL Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2020-12-07 under 510(k) number K201864. 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 YUWELL Infrared Thermometer?

YUWELL Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2020-12-07. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K201864.

When did YUWELL Infrared Thermometer receive FDA 510(k) clearance?

YUWELL Infrared Thermometer received FDA 510(k) clearance on 2020-12-07, under 510(k) number K201864.

Who is the listed applicant for YUWELL Infrared Thermometer?

FDA 510(k)记录将江苏宇悦医疗设备供应有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for YUWELL Infrared Thermometer?

The FDA product code for YUWELL Infrared Thermometer is FLL.

列明Jiangsu Yuyue Medical Equipment & Supply 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。

K261571手动轮椅（H008，PCK7）K252779优威尔® 电子血压计（YE630CR）K253228尤威尔® 电子血压计（YE650AR）K252805优威尔®指夹式脉搏血氧仪（YX105，YX106，YX110，YX310）K242736便携式制氧机（Spirit-3）K250878优威尔® 红外耳温枪（YHT100）；优威尔® 红外耳温枪（YHT107）

查看所有 13 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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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。