FDA 510(k)

Temp Pal (智能温度贴片) 型号：STP-MB01-1

K号: K222588 · 2023-02-17

决定日期2023-02-17

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

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 is the device name listed in this FDA 510(k) record. The listed applicant is Iweecare Co., Ltd.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K222588. 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 Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1?

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Iweecare Co., Ltd.. The 510(k) number is K222588.

When did Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 receive FDA 510(k) clearance?

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 received FDA 510(k) clearance on 2023-02-17, under 510(k) number K222588.

Who is the listed applicant for Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1?

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

What is the FDA product code for Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1?

The FDA product code for Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 is FLL.

列明Iweecare 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。

K202603Temp Pal

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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