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FDA 510(k)

Infrared ear and forehead thermometer, model YI-100

K-Number: K201843 · 2020-10-23

ApplicantWenzhou Yosun Medical Technology Co.,Ltd
Decision Date2020-10-23
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared ear and forehead thermometer, model YI-100 is a medical device manufactured by Wenzhou Yosun Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2020-10-23 under approval number K201843. 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 ear and forehead thermometer, model YI-100?

Infrared ear and forehead thermometer, model YI-100 is a medical device that received FDA 510(k) clearance on 2020-10-23. It is manufactured by Wenzhou Yosun Medical Technology Co.,Ltd. The 510(k) number is K201843.

When was Infrared ear and forehead thermometer, model YI-100 approved by the FDA?

Infrared ear and forehead thermometer, model YI-100 received FDA 510(k) clearance on 2020-10-23, under approval number K201843.

What company makes Infrared ear and forehead thermometer, model YI-100?

Infrared ear and forehead thermometer, model YI-100 is manufactured by Wenzhou Yosun Medical Technology Co.,Ltd.

What is the FDA product code for Infrared ear and forehead thermometer, model YI-100?

The FDA product code for Infrared ear and forehead thermometer, model YI-100 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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