FDA 510(k)

红外额温计 LD-FT-100B

K号: K211629 · 2021-12-08

决定日期2021-12-08

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 forehead thermometer LD-FT-100B is the device name listed in this FDA 510(k) record. The listed applicant is Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-08 under 510(k) number K211629. 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 forehead thermometer LD-FT-100B?

Infrared forehead thermometer LD-FT-100B is a medical device that received FDA 510(k) clearance on 2021-12-08. The listed applicant is Honsun (Nantong) Co., Ltd.. The 510(k) number is K211629.

When did Infrared forehead thermometer LD-FT-100B receive FDA 510(k) clearance?

Infrared forehead thermometer LD-FT-100B received FDA 510(k) clearance on 2021-12-08, under 510(k) number K211629.

Who is the listed applicant for Infrared forehead thermometer LD-FT-100B?

FDA 510(k)记录将江苏恒生医疗器械有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Infrared forehead thermometer LD-FT-100B?

The FDA product code for Infrared forehead thermometer LD-FT-100B is FLL.

列明Honsun (Nantong) 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。

K262658自动数字血压计（LD-526）K252399便携式制氧机 K260260自动数字血压计（LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569）K251795手腕式自动血压计（LD-735，LD-752，LD-753）K192500带听诊器的血压计，水银血压计 K170866Scian自动数字血压计，型号：LD-576，LD-575 & LD-579

查看所有 9 个设备 →

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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