FDA 510(k)

Non-Contact Forehead Thermometer (Models UT306H & UT308H)

N.º K: K203747 · 2021-01-25

SolicitanteUni-Trend Technology (China) Co., Ltd.

Fecha de decisión2021-01-25

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Non-Contact Forehead Thermometer (Models UT306H & UT308H) is the device name listed in this FDA 510(k) record. The listed applicant is Uni-Trend Technology (China) Co., Ltd.. It received FDA 510(k) clearance on 2021-01-25 under 510(k) number K203747. 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 (Models UT306H & UT308H)?

Non-Contact Forehead Thermometer (Models UT306H & UT308H) is a medical device that received FDA 510(k) clearance on 2021-01-25. The listed applicant is Uni-Trend Technology (China) Co., Ltd.. The 510(k) number is K203747.

When did Non-Contact Forehead Thermometer (Models UT306H & UT308H) receive FDA 510(k) clearance?

Non-Contact Forehead Thermometer (Models UT306H & UT308H) received FDA 510(k) clearance on 2021-01-25, under 510(k) number K203747.

Who is the listed applicant for Non-Contact Forehead Thermometer (Models UT306H & UT308H)?

The FDA 510(k) record lists Uni-Trend Technology (China) 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 (Models UT306H & UT308H)?

The FDA product code for Non-Contact Forehead Thermometer (Models UT306H & UT308H) is FLL.

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Otros registros que enlistan a Uni-Trend Technology (China) Co., Ltd. como solicitante

K203656Non-Contact Forehead Thermometer (UT30H)

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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