FDA 510(k)

Digital Thermometer, Model T28, T28L

N.º K: K232678 · 2024-01-31

SolicitanteGuangdong Genial Technology Co., Ltd.

Fecha de decisión2024-01-31

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Digital Thermometer, Model T28, T28L is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Genial Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-31 under 510(k) number K232678. 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 Digital Thermometer, Model T28, T28L?

Digital Thermometer, Model T28, T28L is a medical device that received FDA 510(k) clearance on 2024-01-31. The listed applicant is Guangdong Genial Technology Co., Ltd.. The 510(k) number is K232678.

When did Digital Thermometer, Model T28, T28L receive FDA 510(k) clearance?

Digital Thermometer, Model T28, T28L received FDA 510(k) clearance on 2024-01-31, under 510(k) number K232678.

Who is the listed applicant for Digital Thermometer, Model T28, T28L?

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

What is the FDA product code for Digital Thermometer, Model T28, T28L?

The FDA product code for Digital Thermometer, Model T28, T28L is FLL.

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Otros registros que enlistan a Guangdong Genial Technology Co., Ltd. como solicitante

K240333Wearable Digital Thermometer (T31)K231250Digital Blood Pressure Monitor K231245Digital Blood Pressure Monitor (Arm Type)K231243Finger Clip Pulse Oximeter

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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