FDA 510(k)

红外温度计：型号 YJ600

K号: K232473 · 2024-02-09

申请人Zhuhai Yueja Medical Device Technology Co., Ltd.

决定日期2024-02-09

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 Thermometer: Model YJ600 is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Yueja Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-09 under 510(k) number K232473. 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 Thermometer: Model YJ600?

Infrared Thermometer: Model YJ600 is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is Zhuhai Yueja Medical Device Technology Co., Ltd.. The 510(k) number is K232473.

When did Infrared Thermometer: Model YJ600 receive FDA 510(k) clearance?

Infrared Thermometer: Model YJ600 received FDA 510(k) clearance on 2024-02-09, under 510(k) number K232473.

Who is the listed applicant for Infrared Thermometer: Model YJ600?

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

What is the FDA product code for Infrared Thermometer: Model YJ600?

The FDA product code for Infrared Thermometer: Model YJ600 is FLL.

列明Zhuhai Yueja Medical Device 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。

K232815腕式血压计 K232814电子血压计

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.

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