红外体温计型号E127
K号: K201161 · 2020-10-02
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决定日期2020-10-02
产品代码FLL
咨询委员会医疗设备监管文本翻译如下：
HO
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决定实质等同
器械摘要
Infrared Thermometer Model E127 is the device name listed in this FDA 510(k) record. The listed applicant is Bioland Technology, Ltd.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K201161. 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 Thermometer Model E127?
Infrared Thermometer Model E127 is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Bioland Technology, Ltd.. The 510(k) number is K201161.
When did Infrared Thermometer Model E127 receive FDA 510(k) clearance?
Infrared Thermometer Model E127 received FDA 510(k) clearance on 2020-10-02, under 510(k) number K201161.
Who is the listed applicant for Infrared Thermometer Model E127?
The FDA 510(k) record lists Bioland Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Infrared Thermometer Model E127?
The FDA product code for Infrared Thermometer Model E127 is FLL.
相关临床试验
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。
列明Bioland Technology, 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。
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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