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FDA 510(k)

YUWELL infrared ear thermometer: YHT101, YHT200

K-Number: K203583 · 2021-05-20

ApplicantJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Decision Date2021-05-20
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

YUWELL infrared ear thermometer: YHT101, YHT200 is a medical device manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2021-05-20 under approval number K203583. 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 YUWELL infrared ear thermometer: YHT101, YHT200?

YUWELL infrared ear thermometer: YHT101, YHT200 is a medical device that received FDA 510(k) clearance on 2021-05-20. It is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K203583.

When was YUWELL infrared ear thermometer: YHT101, YHT200 approved by the FDA?

YUWELL infrared ear thermometer: YHT101, YHT200 received FDA 510(k) clearance on 2021-05-20, under approval number K203583.

What company makes YUWELL infrared ear thermometer: YHT101, YHT200?

YUWELL infrared ear thermometer: YHT101, YHT200 is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

What is the FDA product code for YUWELL infrared ear thermometer: YHT101, YHT200?

The FDA product code for YUWELL infrared ear thermometer: YHT101, YHT200 is 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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