FDA 510(k)

Reusable Temperature Probe

Número K: K182751 · 2019-09-06

RequerenteShenzhen Caremed Medical Technology Co., Ltd.

Data da decisão2019-09-06

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reusable Temperature Probe is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Caremed Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K182751. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reusable Temperature Probe?

Reusable Temperature Probe is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Shenzhen Caremed Medical Technology Co., Ltd.. The 510(k) number is K182751.

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

Reusable Temperature Probe received FDA 510(k) clearance on 2019-09-06, under 510(k) number K182751.

Who is the listed applicant for Reusable Temperature Probe?

The FDA 510(k) record lists Shenzhen Caremed 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?

The FDA product code for Reusable Temperature Probe is FLL.

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Outros registros que listam Shenzhen Caremed Medical Technology Co., Ltd. como candidato(a)

K191279Disposable SpO2 Sensor K182755Disposable Temperature Probe K182433Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff K153184Caremed Reusable & Disposable SPO2 Sensors K153188Caremed patient cable and leadwires

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.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.

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