FDA 510(k)

非接触式额温计（FC-IR2000，FC-IR205，FC-IR202，FC-IR206，FC-IR207，FC-IR209）

K号: K243136 · 2025-02-14

决定日期2025-02-14

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 Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Finicare Co., Ltd.. It received FDA 510(k) clearance on 2025-02-14 under 510(k) number K243136. 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 Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)?

Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) is a medical device that received FDA 510(k) clearance on 2025-02-14. The listed applicant is Shenzhen Finicare Co., Ltd.. The 510(k) number is K243136.

When did Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) receive FDA 510(k) clearance?

Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) received FDA 510(k) clearance on 2025-02-14, under 510(k) number K243136.

Who is the listed applicant for Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)?

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

What is the FDA product code for Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)?

The FDA product code for Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) is FLL.

列明Shenzhen Finicare 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。

K252769上臂电子血压计（FC-BP107，FC-BP123，FC-BP125，FC-BP126，FC-BP127，FC-BP116）K242721上臂电子血压计（FC-BP103，FC-BP106，FC-BP113，FC-BP120，FC-BP121，FC-BP130，FC-BP131）K231367腕式电子血压计（型号 FC-BP200、FC-BP201、FC-BP210、FC-BP211、FC-BP220、FC-BP221）K220113上臂电子血压计（型号 FC-BP100，FC-BP101，FC-BP102，FC-BP110，FC-BP111，FC-BP112）K181215红外体温计

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.

官方来源

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