FDA 510(k)

Med-link 可重复使用温度探头，Med-link 一次性温度探头

K号: K193338 · 2020-08-25

申请人Shenzhen Med-Link Electronics Tech Co., Ltd.

决定日期2020-08-25

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

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2020-08-25 under 510(k) number K193338. 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 Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes is a medical device that received FDA 510(k) clearance on 2020-08-25. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K193338.

When did Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes receive FDA 510(k) clearance?

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes received FDA 510(k) clearance on 2020-08-25, under 510(k) number K193338.

Who is the listed applicant for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

The FDA product code for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes is FLL.

列明Shenzhen Med-Link Electronics Tech 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。

K251160无菌温度探头（型号：W0001ES，W0028ES，W0101FS-A，W0101FS-P，W0099LS，W0099FS，W0099PS）K220448一次性非侵入式脑电图传感器 K220447Med-link 一次性心电图电缆和导联线 K212752Med-link 脉搏血氧计 K210441失禁探头 K202743Med-Link Temp-pulse 血氧计

查看所有 11 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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