FDA 510(k)

Dual Mode Infrared Thermometer

Número K: K163256 · 2017-04-06

Data da decisão2017-04-06

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dual Mode Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Intelliworks, LLC. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K163256. 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 Dual Mode Infrared Thermometer?

Dual Mode Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Intelliworks, LLC. The 510(k) number is K163256.

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

Dual Mode Infrared Thermometer received FDA 510(k) clearance on 2017-04-06, under 510(k) number K163256.

Who is the listed applicant for Dual Mode Infrared Thermometer?

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

What is the FDA product code for Dual Mode Infrared Thermometer?

The FDA product code for Dual Mode Infrared Thermometer is FLL.

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Dispositivos Relacionados (Código: FLL)

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