FDA 510(k)

Fever Scout™ 连续监测体温计

K号: K162137 · 2017-01-19

决定日期2017-01-19

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

Fever Scout™ Continuous Monitoring thermometer is the device name listed in this FDA 510(k) record. The listed applicant is VivaLNK, Inc.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K162137. 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 Fever Scout™ Continuous Monitoring thermometer?

Fever Scout™ Continuous Monitoring thermometer is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is VivaLNK, Inc.. The 510(k) number is K162137.

When did Fever Scout™ Continuous Monitoring thermometer receive FDA 510(k) clearance?

Fever Scout™ Continuous Monitoring thermometer received FDA 510(k) clearance on 2017-01-19, under 510(k) number K162137.

Who is the listed applicant for Fever Scout™ Continuous Monitoring thermometer?

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

What is the FDA product code for Fever Scout™ Continuous Monitoring thermometer?

The FDA product code for Fever Scout™ Continuous Monitoring thermometer is FLL.

列明VivaLNK, Inc.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。

K191870VV330连续心电图平台，VivaLNK粘性贴片 K181013Fever Scout

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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