FDA 510(k)

Infrared Body Thermometer

Número K: K200781 · 2020-12-09

Data da decisão2020-12-09

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Body Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Heitaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-12-09 under 510(k) number K200781. 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 Infrared Body Thermometer?

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

When did Infrared Body Thermometer receive FDA 510(k) clearance?

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

Who is the listed applicant for Infrared Body Thermometer?

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

What is the FDA product code for Infrared Body Thermometer?

The FDA product code for Infrared Body Thermometer is FLL.

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