FDA 510(k)

Infrared Thermometer

N.º K: K201508 · 2021-03-09

SolicitanteDongguan Prestige Sporting Goods Co., Ltd.

Fecha de decisión2021-03-09

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Prestige Sporting Goods Co., Ltd.. It received FDA 510(k) clearance on 2021-03-09 under 510(k) number K201508. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Infrared Thermometer?

Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2021-03-09. The listed applicant is Dongguan Prestige Sporting Goods Co., Ltd.. The 510(k) number is K201508.

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

Infrared Thermometer received FDA 510(k) clearance on 2021-03-09, under 510(k) number K201508.

Who is the listed applicant for Infrared Thermometer?

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

What is the FDA product code for Infrared Thermometer?

The FDA product code for Infrared Thermometer is FLL.

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Dispositivos relacionados (Código: FLL)

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Fuente oficial

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