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FDA 510(k)

Infrared Thermometer (Model: Y20001, Y20002)

K-Number: K221800 · 2022-12-14

ApplicantZhangzhou Easepal Medical Science and Technology Co., Ltd.
Decision Date2022-12-14
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer (Model: Y20001, Y20002) is a medical device manufactured by Zhangzhou Easepal Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-14 under approval number K221800. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Zhangzhou Easepal Medical Science and Technology Co., Ltd.. The 510(k) number is K221800.

When was Infrared Thermometer (Model: Y20001, Y20002) approved by the FDA?

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

What company makes Infrared Thermometer (Model: Y20001, Y20002)?

Infrared Thermometer (Model: Y20001, Y20002) is manufactured by Zhangzhou Easepal Medical Science and Technology Co., Ltd..

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

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

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Related Devices (Code: FLL)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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