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FDA 510(k)

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer

N.º K: K181239 · 2018-10-29

SolicitanteJoytech Healthcare Co. , Ltd.
Fecha de decisión2018-10-29
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2018-10-29 under 510(k) number K181239. 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, Infrared Ear/Forehead Thermometer?

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2018-10-29. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K181239.

When did Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer receive FDA 510(k) clearance?

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer received FDA 510(k) clearance on 2018-10-29, under 510(k) number K181239.

Who is the listed applicant for Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer?

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

What is the FDA product code for Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer?

The FDA product code for Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer is FLL.

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Dispositivos relacionados (Código: FLL)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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