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FDA 510(k)

Dual Mode Infrared Thermometer

N.º K: K163256 · 2017-04-06

SolicitanteIntelliworks, LLC
Fecha de decisión2017-04-06
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Dual Mode Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Intelliworks, LLC. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K163256. 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 Dual Mode Infrared Thermometer?

Dual Mode Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Intelliworks, LLC. The 510(k) number is K163256.

When did Dual Mode Infrared Thermometer receive FDA 510(k) clearance?

Dual Mode Infrared Thermometer received FDA 510(k) clearance on 2017-04-06, under 510(k) number K163256.

Who is the listed applicant for Dual Mode Infrared Thermometer?

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

What is the FDA product code for Dual Mode Infrared Thermometer?

The FDA product code for Dual Mode Infrared 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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