FDA 510(k)

Wireless Intelligent Thermometer

Número K: K182437 · 2019-05-05

RequerenteShenzhen Jumper Medical Equipment Co., Ltd.

Data da decisão2019-05-05

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wireless Intelligent Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jumper Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-05-05 under 510(k) number K182437. 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 Wireless Intelligent Thermometer?

Wireless Intelligent Thermometer is a medical device that received FDA 510(k) clearance on 2019-05-05. The listed applicant is Shenzhen Jumper Medical Equipment Co., Ltd.. The 510(k) number is K182437.

When did Wireless Intelligent Thermometer receive FDA 510(k) clearance?

Wireless Intelligent Thermometer received FDA 510(k) clearance on 2019-05-05, under 510(k) number K182437.

Who is the listed applicant for Wireless Intelligent Thermometer?

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

What is the FDA product code for Wireless Intelligent Thermometer?

The FDA product code for Wireless Intelligent Thermometer is FLL.

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Outros registros que listam Shenzhen Jumper Medical Equipment Co., Ltd. como candidato(a)

K231310Electronic Blood Pressure Monitor K182871Mini TENS Therapy Device K182495Electronic Blood Pressure Monitor K172795Infrared Thermometer K170965Fingertip Pulse Oximeter

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.

Fonte oficial

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