FDA 510(k)

Non-contact Forehead Thermometer

N.º K: K161735 · 2016-11-17

SolicitanteShenzhen Dongdixin Technology Co., Ltd.

Fecha de decisión2016-11-17

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Non-contact Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K161735. 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 Non-contact Forehead Thermometer?

Non-contact Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K161735.

When did Non-contact Forehead Thermometer receive FDA 510(k) clearance?

Non-contact Forehead Thermometer received FDA 510(k) clearance on 2016-11-17, under 510(k) number K161735.

Who is the listed applicant for Non-contact Forehead Thermometer?

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

What is the FDA product code for Non-contact Forehead Thermometer?

The FDA product code for Non-contact Forehead Thermometer is FLL.

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Fuente oficial

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