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FDA 510(k)

Infrared Body Thermometer

K-Number: K200781 · 2020-12-09

ApplicantHeitaida Technology Co., Ltd.
Decision Date2020-12-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Body Thermometer is a medical device manufactured by Heitaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-12-09 under approval number K200781. 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 Body Thermometer?

Infrared Body Thermometer is a medical device that received FDA 510(k) clearance on 2020-12-09. It is manufactured by Heitaida Technology Co., Ltd.. The 510(k) number is K200781.

When was Infrared Body Thermometer approved by the FDA?

Infrared Body Thermometer received FDA 510(k) clearance on 2020-12-09, under approval number K200781.

What company makes Infrared Body Thermometer?

Infrared Body Thermometer is manufactured by Heitaida Technology Co., Ltd..

What is the FDA product code for Infrared Body Thermometer?

The FDA product code for Infrared Body Thermometer is FLL.

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Official Source

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

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