FDA 510(k)

Infrared Thermometer, Model: HW-1

Número K: K211583 · 2021-09-03

RequerenteDongguan Simzo Electronic Technology Co., Ltd.

Data da decisão2021-09-03

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Thermometer, Model: HW-1 is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Simzo Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K211583. 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 Thermometer, Model: HW-1?

Infrared Thermometer, Model: HW-1 is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Dongguan Simzo Electronic Technology Co., Ltd.. The 510(k) number is K211583.

When did Infrared Thermometer, Model: HW-1 receive FDA 510(k) clearance?

Infrared Thermometer, Model: HW-1 received FDA 510(k) clearance on 2021-09-03, under 510(k) number K211583.

Who is the listed applicant for Infrared Thermometer, Model: HW-1?

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

What is the FDA product code for Infrared Thermometer, Model: HW-1?

The FDA product code for Infrared Thermometer, Model: HW-1 is FLL.

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Fonte oficial

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