FDA 510(k)

无线智能体温计

K号: K233192 · 2024-04-05

决定日期2024-04-05

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

Wireless Smart Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Famidoc Technology Company Limited. It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K233192. 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 Wireless Smart Thermometer?

Wireless Smart Thermometer is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Famidoc Technology Company Limited. The 510(k) number is K233192.

When did Wireless Smart Thermometer receive FDA 510(k) clearance?

Wireless Smart Thermometer received FDA 510(k) clearance on 2024-04-05, under 510(k) number K233192.

Who is the listed applicant for Wireless Smart Thermometer?

The FDA 510(k) record lists Famidoc Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless Smart Thermometer?

The FDA product code for Wireless Smart Thermometer is FLL.

列明Famidoc Technology Company Limited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。

K222887上臂血压计/自动无线智能血压计 K191673上臂血压监测仪

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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