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FDA 510(k)

FMT Reusable Temperature Probes

N.º K: K213100 · 2023-07-18

SolicitanteMetko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti
Fecha de decisión2023-07-18
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

FMT Reusable Temperature Probes is the device name listed in this FDA 510(k) record. The listed applicant is Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti. It received FDA 510(k) clearance on 2023-07-18 under 510(k) number K213100. 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 FMT Reusable Temperature Probes?

FMT Reusable Temperature Probes is a medical device that received FDA 510(k) clearance on 2023-07-18. The listed applicant is Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti. The 510(k) number is K213100.

When did FMT Reusable Temperature Probes receive FDA 510(k) clearance?

FMT Reusable Temperature Probes received FDA 510(k) clearance on 2023-07-18, under 510(k) number K213100.

Who is the listed applicant for FMT Reusable Temperature Probes?

The FDA 510(k) record lists Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FMT Reusable Temperature Probes?

The FDA product code for FMT Reusable Temperature Probes 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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