FDA 510(k)

Body Infrared Thermometer HT-820D

Número K: K202591 · 2021-03-09

RequerenteDongguan Xintai Instrument Co., Ltd.

Data da decisão2021-03-09

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Body Infrared Thermometer HT-820D is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Xintai Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-03-09 under 510(k) number K202591. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Dongguan Xintai Instrument Co., Ltd.. The 510(k) number is K202591.

When did Body Infrared Thermometer HT-820D receive FDA 510(k) clearance?

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

Who is the listed applicant for Body Infrared Thermometer HT-820D?

The FDA 510(k) record lists Dongguan Xintai Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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