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FDA 510(k)

Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)

N.º K: K152640 · 2016-03-28

SolicitanteFudakang Industries Co., Ltd.
Fecha de decisión2016-03-28
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) is the device name listed in this FDA 510(k) record. The listed applicant is Fudakang Industries Co., Ltd.. It received FDA 510(k) clearance on 2016-03-28 under 510(k) number K152640. 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 Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)?

Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) is a medical device that received FDA 510(k) clearance on 2016-03-28. The listed applicant is Fudakang Industries Co., Ltd.. The 510(k) number is K152640.

When did Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) receive FDA 510(k) clearance?

Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) received FDA 510(k) clearance on 2016-03-28, under 510(k) number K152640.

Who is the listed applicant for Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)?

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

What is the FDA product code for Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)?

The FDA product code for Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) 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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