FDA 510(k)

Wearable Digital Thermometer (T31)

N.º K: K240333 · 2024-10-30

SolicitanteGuangdong Genial Technology Co., Ltd.

Fecha de decisión2024-10-30

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Wearable Digital Thermometer (T31) 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 2024-10-30 under 510(k) number K240333. 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 Wearable Digital Thermometer (T31)?

Wearable Digital Thermometer (T31) is a medical device that received FDA 510(k) clearance on 2024-10-30. The listed applicant is Guangdong Genial Technology Co., Ltd.. The 510(k) number is K240333.

When did Wearable Digital Thermometer (T31) receive FDA 510(k) clearance?

Wearable Digital Thermometer (T31) received FDA 510(k) clearance on 2024-10-30, under 510(k) number K240333.

Who is the listed applicant for Wearable Digital Thermometer (T31)?

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 Wearable Digital Thermometer (T31)?

The FDA product code for Wearable Digital Thermometer (T31) is FLL.

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

K232678Digital Thermometer, Model T28, T28L 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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