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FDA 510(k)

NC° Thermometer (Gen 3), Model Number: NCTG3

N.º K: K223522 · 2023-06-20

SolicitanteXiamen Intretech, Inc.
Fecha de decisión2023-06-20
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

NC° Thermometer (Gen 3), Model Number: NCTG3 is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Intretech, Inc.. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K223522. 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 NC° Thermometer (Gen 3), Model Number: NCTG3?

NC° Thermometer (Gen 3), Model Number: NCTG3 is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Xiamen Intretech, Inc.. The 510(k) number is K223522.

When did NC° Thermometer (Gen 3), Model Number: NCTG3 receive FDA 510(k) clearance?

NC° Thermometer (Gen 3), Model Number: NCTG3 received FDA 510(k) clearance on 2023-06-20, under 510(k) number K223522.

Who is the listed applicant for NC° Thermometer (Gen 3), Model Number: NCTG3?

The FDA 510(k) record lists Xiamen Intretech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NC° Thermometer (Gen 3), Model Number: NCTG3?

The FDA product code for NC° Thermometer (Gen 3), Model Number: NCTG3 is FLL.

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Dispositivos relacionados (Código: FLL)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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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