FDA 510(k)

Infrared Forehead Thermometer (Model IR-FT)

N.º K: K191668 · 2019-10-18

SolicitanteComper Chuangxiang (Beijing) Technology Co., Ltd.

Fecha de decisión2019-10-18

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Infrared Forehead Thermometer (Model IR-FT) is the device name listed in this FDA 510(k) record. The listed applicant is Comper Chuangxiang (Beijing) Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K191668. 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 Forehead Thermometer (Model IR-FT)?

Infrared Forehead Thermometer (Model IR-FT) is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Comper Chuangxiang (Beijing) Technology Co., Ltd.. The 510(k) number is K191668.

When did Infrared Forehead Thermometer (Model IR-FT) receive FDA 510(k) clearance?

Infrared Forehead Thermometer (Model IR-FT) received FDA 510(k) clearance on 2019-10-18, under 510(k) number K191668.

Who is the listed applicant for Infrared Forehead Thermometer (Model IR-FT)?

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

What is the FDA product code for Infrared Forehead Thermometer (Model IR-FT)?

The FDA product code for Infrared Forehead Thermometer (Model IR-FT) is FLL.

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Otros registros que enlistan a Comper Chuangxiang (Beijing) Technology Co., Ltd. como solicitante

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Dispositivos relacionados (Código: FLL)

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Fuente oficial

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