FDA 510(k)

YUWELL Infrared Thermometer

N.º K: K201864 · 2020-12-07

SolicitanteJiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Fecha de decisión2020-12-07

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

YUWELL Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2020-12-07 under 510(k) number K201864. 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 YUWELL Infrared Thermometer?

YUWELL Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2020-12-07. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K201864.

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

YUWELL Infrared Thermometer received FDA 510(k) clearance on 2020-12-07, under 510(k) number K201864.

Who is the listed applicant for YUWELL Infrared Thermometer?

The FDA 510(k) record lists Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YUWELL Infrared Thermometer?

The FDA product code for YUWELL Infrared Thermometer is FLL.

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Otros registros que enlistan a Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. como solicitante

K261571Manual Wheelchair (H008, PCK7)K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)K242736Portable Oxygen Concentrator (Spirit-3)K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: FLL)

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

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