FDA 510(k)

Infared Thermometer

Número K: K191251 · 2019-10-15

RequerenteShenzhen Calibeur Industries Co., Ltd.

Data da decisão2019-10-15

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Calibeur Industries Co., Ltd.. It received FDA 510(k) clearance on 2019-10-15 under 510(k) number K191251. 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 Infared Thermometer?

Infared Thermometer is a medical device that received FDA 510(k) clearance on 2019-10-15. The listed applicant is Shenzhen Calibeur Industries Co., Ltd.. The 510(k) number is K191251.

When did Infared Thermometer receive FDA 510(k) clearance?

Infared Thermometer received FDA 510(k) clearance on 2019-10-15, under 510(k) number K191251.

Who is the listed applicant for Infared Thermometer?

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

What is the FDA product code for Infared Thermometer?

The FDA product code for Infared Thermometer is FLL.

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Dispositivos Relacionados (Código: FLL)

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