FDA 510(k)

红外额温计，型号JZK-601，JZK-602，JZK-603

K号: K203707 · 2021-03-12

申请人Shenzhen Zhengkang Technology Co., Ltd.

决定日期2021-03-12

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, Model JZK-601, JZK-602, JZK-603 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Zhengkang Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-03-12 under 510(k) number K203707. 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, Model JZK-601, JZK-602, JZK-603?

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is a medical device that received FDA 510(k) clearance on 2021-03-12. The listed applicant is Shenzhen Zhengkang Technology Co., Ltd.. The 510(k) number is K203707.

When did Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 receive FDA 510(k) clearance?

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 received FDA 510(k) clearance on 2021-03-12, under 510(k) number K203707.

Who is the listed applicant for Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603?

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

What is the FDA product code for Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603?

The FDA product code for Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is FLL.

列明Shenzhen Zhengkang 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。

K213984脉搏血氧仪（型号：JZK-301,JZK-303,JZK-305,JZK-307）K191894上臂血压监测仪

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。

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官方来源

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