FDA 510(k)

Non-contact Infrared Body Thermometer, model:HTD8823US

Número K: K200159 · 2021-01-05

Data da decisão2021-01-05

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Non-contact Infrared Body Thermometer, model:HTD8823US is the device name listed in this FDA 510(k) record. The listed applicant is Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-05 under 510(k) number K200159. 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 Non-contact Infrared Body Thermometer, model:HTD8823US?

Non-contact Infrared Body Thermometer, model:HTD8823US is a medical device that received FDA 510(k) clearance on 2021-01-05. The listed applicant is Hetaida Technology Co., Ltd.. The 510(k) number is K200159.

When did Non-contact Infrared Body Thermometer, model:HTD8823US receive FDA 510(k) clearance?

Non-contact Infrared Body Thermometer, model:HTD8823US received FDA 510(k) clearance on 2021-01-05, under 510(k) number K200159.

Who is the listed applicant for Non-contact Infrared Body Thermometer, model:HTD8823US?

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

What is the FDA product code for Non-contact Infrared Body Thermometer, model:HTD8823US?

The FDA product code for Non-contact Infrared Body Thermometer, model:HTD8823US is FLL.

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Dispositivos Relacionados (Código: FLL)

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