FDA 510(k)

耳温计（EAR-E101）；耳温计（EAR-E102）；耳温计（EAR-E103）

K号: K250470 · 2025-06-23

申请人Shenzhen AOJ Medical Technology Co., Ltd.

决定日期2025-06-23

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 (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-23 under 510(k) number K250470. 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 (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)?

Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) is a medical device that received FDA 510(k) clearance on 2025-06-23. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K250470.

When did Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) receive FDA 510(k) clearance?

Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) received FDA 510(k) clearance on 2025-06-23, under 510(k) number K250470.

Who is the listed applicant for Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)?

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

What is the FDA product code for Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)?

The FDA product code for Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) is FLL.

列明Shenzhen AOJ Medical Technology 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。

K260276上臂血压计型号：ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro K250161腕式血压计（AOJ-35A）；腕式血压计（AOJ-35B）；腕式血压计（WRS-35B）；腕式血压计（AOJ-35D）；腕式血压计（AOJ-35E）；腕式血压计（AOJ-35F）；腕式血压计（AOJ-35G）；腕式血压计（WRS-35G）；腕式血压计（WRS-35H）；腕式血压计（WRS-35K）；腕式血压计（WRS-35N）；腕式血压计（WRS-35P）；腕式血压计（WRS-35P）K244000上臂血压计 (ARM-30A+);上臂血压计 (ARM-30G2);上臂血压计 (ARM-30Q);上臂血压计 (ARM-30E+);K250116上臂血压计 (ARM-30H); 上臂血压计 (ARM-30J); 上臂血压计 (ARM-30K); 上臂血压计 (ARM-90B)K232989脉搏血氧仪（AOJ-70A）；脉搏血氧仪（AOJ-70B）；脉搏血氧仪（AOJ-70C）；脉搏血氧仪（AOJ-70D）；脉搏血氧仪（AOJ-70E）K232128红外体温计（AOJ-20A）；红外体温计（AOJ-20Y）

查看所有 17 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.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.K250401AION TempShield™Aion Biosystems, Inc.

官方来源

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