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FDA 510(k)

Infrared Thermometer, Breeze model

K-Number: K191283 · 2019-10-18

ApplicantSuzhou Melodicare Medical Technology Co., Ltd.
Decision Date2019-10-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer, Breeze model is a medical device manufactured by Suzhou Melodicare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-10-18 under approval number K191283. 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, Breeze model?

Infrared Thermometer, Breeze model is a medical device that received FDA 510(k) clearance on 2019-10-18. It is manufactured by Suzhou Melodicare Medical Technology Co., Ltd.. The 510(k) number is K191283.

When was Infrared Thermometer, Breeze model approved by the FDA?

Infrared Thermometer, Breeze model received FDA 510(k) clearance on 2019-10-18, under approval number K191283.

What company makes Infrared Thermometer, Breeze model?

Infrared Thermometer, Breeze model is manufactured by Suzhou Melodicare Medical Technology Co., Ltd..

What is the FDA product code for Infrared Thermometer, Breeze model?

The FDA product code for Infrared Thermometer, Breeze model 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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