FDA 510(k)

Termômetro de Orelha Infravermelho Digital Microlife

Número K: K170219 · 2017-07-20

RequerenteMicrolife Intellectual Property GmbH

Data da decisão2017-07-20

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Microlife Digital Infrared Ear Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2017-07-20 under 510(k) number K170219. 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 Microlife Digital Infrared Ear Thermometer?

Microlife Digital Infrared Ear Thermometer is a medical device that received FDA 510(k) clearance on 2017-07-20. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K170219.

When did Microlife Digital Infrared Ear Thermometer receive FDA 510(k) clearance?

Microlife Digital Infrared Ear Thermometer received FDA 510(k) clearance on 2017-07-20, under 510(k) number K170219.

Who is the listed applicant for Microlife Digital Infrared Ear Thermometer?

The FDA 510(k) record lists Microlife Intellectual Property GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microlife Digital Infrared Ear Thermometer?

The FDA product code for Microlife Digital Infrared Ear Thermometer is FLL.

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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.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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