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FDA 510(k)

Body Infrared Thermometer HT-820D

K-Number: K202591 · 2021-03-09

ApplicantDongguan Xintai Instrument Co., Ltd.
Decision Date2021-03-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Body Infrared Thermometer HT-820D is a medical device manufactured by Dongguan Xintai Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-03-09 under approval number K202591. 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 Body Infrared Thermometer HT-820D?

Body Infrared Thermometer HT-820D is a medical device that received FDA 510(k) clearance on 2021-03-09. It is manufactured by Dongguan Xintai Instrument Co., Ltd.. The 510(k) number is K202591.

When was Body Infrared Thermometer HT-820D approved by the FDA?

Body Infrared Thermometer HT-820D received FDA 510(k) clearance on 2021-03-09, under approval number K202591.

What company makes Body Infrared Thermometer HT-820D?

Body Infrared Thermometer HT-820D is manufactured by Dongguan Xintai Instrument Co., Ltd..

What is the FDA product code for Body Infrared Thermometer HT-820D?

The FDA product code for Body Infrared Thermometer HT-820D is FLL.

Related Devices (Code: 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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