FDA 510(k)

耳温计，型号ET005，ET008，ET009

K号: K213084 · 2022-02-25

申请人Guangzhou Berrcom Medical Device Co., Ltd.

决定日期2022-02-25

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

Ear Thermometer, Model ET005, ET008, ET009 is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K213084. 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 Ear Thermometer, Model ET005, ET008, ET009?

Ear Thermometer, Model ET005, ET008, ET009 is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K213084.

When did Ear Thermometer, Model ET005, ET008, ET009 receive FDA 510(k) clearance?

Ear Thermometer, Model ET005, ET008, ET009 received FDA 510(k) clearance on 2022-02-25, under 510(k) number K213084.

Who is the listed applicant for Ear Thermometer, Model ET005, ET008, ET009?

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

What is the FDA product code for Ear Thermometer, Model ET005, ET008, ET009?

The FDA product code for Ear Thermometer, Model ET005, ET008, ET009 is FLL.

列明Guangzhou Berrcom Medical Device 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。

K214077数字温度计，型号：DT007，DT008 K213746数字体温计，型号DT101，DT102 K213079耳温计，型号ET001 K213082非接触式红外体温计，型号 JXB-315，JXB-319，JXB-320，JXB-311 K191570红外体温计型号MD-H30

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.

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