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FDA 510(k)

Infrared Thermometer (Model K9)

N.º K: K203497 · 2021-10-08

SolicitanteKangzhan Communication Electronics Co., Ltd.
Fecha de decisión2021-10-08
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Infrared Thermometer (Model K9) is the device name listed in this FDA 510(k) record. The listed applicant is Kangzhan Communication Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K203497. 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 (Model K9)?

Infrared Thermometer (Model K9) is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Kangzhan Communication Electronics Co., Ltd.. The 510(k) number is K203497.

When did Infrared Thermometer (Model K9) receive FDA 510(k) clearance?

Infrared Thermometer (Model K9) received FDA 510(k) clearance on 2021-10-08, under 510(k) number K203497.

Who is the listed applicant for Infrared Thermometer (Model K9)?

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

What is the FDA product code for Infrared Thermometer (Model K9)?

The FDA product code for Infrared Thermometer (Model K9) 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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