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FDA 510(k)

Swaive Thermometer SWT1A

N.º K: K170723 · 2018-10-25

SolicitanteE-Care Technology Co., Ltd.
Fecha de decisión2018-10-25
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Swaive Thermometer SWT1A is the device name listed in this FDA 510(k) record. The listed applicant is E-Care Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K170723. 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 Swaive Thermometer SWT1A?

Swaive Thermometer SWT1A is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is E-Care Technology Co., Ltd.. The 510(k) number is K170723.

When did Swaive Thermometer SWT1A receive FDA 510(k) clearance?

Swaive Thermometer SWT1A received FDA 510(k) clearance on 2018-10-25, under 510(k) number K170723.

Who is the listed applicant for Swaive Thermometer SWT1A?

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

What is the FDA product code for Swaive Thermometer SWT1A?

The FDA product code for Swaive Thermometer SWT1A 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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