FDA 510(k)

Reusable Temperature Probe, Disposable Temperature Probe

N.º K: K223807 · 2023-08-25

SolicitanteShenzhen Sino-K Medical Technology Co.,Ltd

Fecha de decisión2023-08-25

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Reusable Temperature Probe, Disposable Temperature Probe is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K223807. 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 Reusable Temperature Probe, Disposable Temperature Probe?

Reusable Temperature Probe, Disposable Temperature Probe is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. The 510(k) number is K223807.

When did Reusable Temperature Probe, Disposable Temperature Probe receive FDA 510(k) clearance?

Reusable Temperature Probe, Disposable Temperature Probe received FDA 510(k) clearance on 2023-08-25, under 510(k) number K223807.

Who is the listed applicant for Reusable Temperature Probe, Disposable Temperature Probe?

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

What is the FDA product code for Reusable Temperature Probe, Disposable Temperature Probe?

The FDA product code for Reusable Temperature Probe, Disposable Temperature Probe is FLL.

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Otros registros que enlistan a Shenzhen Sino-K Medical Technology Co.,Ltd como solicitante

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Dispositivos relacionados (Código: FLL)

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.K250470Termómetro auricular (EAR-E101); Termómetro auricular (EAR-E102); Termómetro auricular (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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