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FDA 510(k)

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)

N.º K: K210014 · 2021-06-04

SolicitanteGuandong Genial Technology Co., Limited
Fecha de decisión2021-06-04
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) is the device name listed in this FDA 510(k) record. The listed applicant is Guandong Genial Technology Co., Limited. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K210014. 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: T80, T81, T82, T83, T84, T85)?

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Guandong Genial Technology Co., Limited. The 510(k) number is K210014.

When did Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) receive FDA 510(k) clearance?

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) received FDA 510(k) clearance on 2021-06-04, under 510(k) number K210014.

Who is the listed applicant for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)?

The FDA 510(k) record lists Guandong Genial Technology Co., Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)?

The FDA product code for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) 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.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

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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