FDA 510(k)

Infrared Non-contact Thermometer, Model ACT8100

Número K: K162509 · 2017-03-10

Data da decisão2017-03-10

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Non-contact Thermometer, Model ACT8100 is the device name listed in this FDA 510(k) record. The listed applicant is Easywell Biomedicals, Inc.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K162509. 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 Non-contact Thermometer, Model ACT8100?

Infrared Non-contact Thermometer, Model ACT8100 is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is Easywell Biomedicals, Inc.. The 510(k) number is K162509.

When did Infrared Non-contact Thermometer, Model ACT8100 receive FDA 510(k) clearance?

Infrared Non-contact Thermometer, Model ACT8100 received FDA 510(k) clearance on 2017-03-10, under 510(k) number K162509.

Who is the listed applicant for Infrared Non-contact Thermometer, Model ACT8100?

The FDA 510(k) record lists Easywell Biomedicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Non-contact Thermometer, Model ACT8100?

The FDA product code for Infrared Non-contact Thermometer, Model ACT8100 is FLL.

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