FDA 510(k)

Infrared ear and forehead thermometer, model YI-100

N.º K: K201843 · 2020-10-23

SolicitanteWenzhou Yosun Medical Technology Co.,Ltd

Fecha de decisión2020-10-23

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Infrared ear and forehead thermometer, model YI-100 is the device name listed in this FDA 510(k) record. The listed applicant is Wenzhou Yosun Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K201843. 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 ear and forehead thermometer, model YI-100?

Infrared ear and forehead thermometer, model YI-100 is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Wenzhou Yosun Medical Technology Co.,Ltd. The 510(k) number is K201843.

When did Infrared ear and forehead thermometer, model YI-100 receive FDA 510(k) clearance?

Infrared ear and forehead thermometer, model YI-100 received FDA 510(k) clearance on 2020-10-23, under 510(k) number K201843.

Who is the listed applicant for Infrared ear and forehead thermometer, model YI-100?

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

What is the FDA product code for Infrared ear and forehead thermometer, model YI-100?

The FDA product code for Infrared ear and forehead thermometer, model YI-100 is FLL.

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Otros registros que enlistan a Wenzhou Yosun Medical Technology Co.,Ltd como solicitante

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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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