FDA 510(k)

红外体温计（型号：Y20001，Y20002）

K号: K221800 · 2022-12-14

申请人Zhangzhou Easepal Medical Science and Technology Co., Ltd.

决定日期2022-12-14

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 Thermometer (Model: Y20001, Y20002) is the device name listed in this FDA 510(k) record. The listed applicant is Zhangzhou Easepal Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-14 under 510(k) number K221800. 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: Y20001, Y20002)?

Infrared Thermometer (Model: Y20001, Y20002) is a medical device that received FDA 510(k) clearance on 2022-12-14. The listed applicant is Zhangzhou Easepal Medical Science and Technology Co., Ltd.. The 510(k) number is K221800.

When did Infrared Thermometer (Model: Y20001, Y20002) receive FDA 510(k) clearance?

Infrared Thermometer (Model: Y20001, Y20002) received FDA 510(k) clearance on 2022-12-14, under 510(k) number K221800.

Who is the listed applicant for Infrared Thermometer (Model: Y20001, Y20002)?

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

What is the FDA product code for Infrared Thermometer (Model: Y20001, Y20002)?

The FDA product code for Infrared Thermometer (Model: Y20001, Y20002) is FLL.

列明Zhangzhou Easepal Medical Science and 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。

K240373空气压缩腿部按摩器（MM0520，MM0521，MM0522）K213023血压计（型号：Y30001）

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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