FDA 510(k)

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)

N.º K: K160308 · 2016-07-15

SolicitanteFudakang Industrial Co., Ltd.

Fecha de decisión2016-07-15

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) is the device name listed in this FDA 510(k) record. The listed applicant is Fudakang Industrial Co., Ltd.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K160308. 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 Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)?

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Fudakang Industrial Co., Ltd.. The 510(k) number is K160308.

When did Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) receive FDA 510(k) clearance?

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) received FDA 510(k) clearance on 2016-07-15, under 510(k) number K160308.

Who is the listed applicant for Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)?

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

What is the FDA product code for Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)?

The FDA product code for Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) is FLL.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Fudakang Industrial Co., Ltd. como solicitante

K172121Digital Thermometer

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

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.