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FDA 510(k)

Cloud Smart Thermometer

N.º K: K160306 · 2016-12-13

SolicitanteGuangzhou Bosma Technology Co, Ltd.
Fecha de decisión2016-12-13
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Cloud Smart Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Bosma Technology Co, Ltd.. It received FDA 510(k) clearance on 2016-12-13 under 510(k) number K160306. 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 Cloud Smart Thermometer?

Cloud Smart Thermometer is a medical device that received FDA 510(k) clearance on 2016-12-13. The listed applicant is Guangzhou Bosma Technology Co, Ltd.. The 510(k) number is K160306.

When did Cloud Smart Thermometer receive FDA 510(k) clearance?

Cloud Smart Thermometer received FDA 510(k) clearance on 2016-12-13, under 510(k) number K160306.

Who is the listed applicant for Cloud Smart Thermometer?

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

What is the FDA product code for Cloud Smart Thermometer?

The FDA product code for Cloud Smart Thermometer 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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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