FDA 510(k)

Termómetro Infrarrojo Digital Microlife

N.º K: K183663 · 2019-07-16

SolicitanteMicrolife Intellectual Property GmbH

Fecha de decisión2019-07-16

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del 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 2019-07-16 under 510(k) number K183663. 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 Microlife Digital Infrared Ear Thermometer?

Microlife Digital Infrared Ear Thermometer is a medical device that received FDA 510(k) clearance on 2019-07-16. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K183663.

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

Microlife Digital Infrared Ear Thermometer received FDA 510(k) clearance on 2019-07-16, under 510(k) number K183663.

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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Otros registros que enlistan a Microlife Intellectual Property GmbH como solicitante

K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)K211776Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)K211288Monitor de Presión Arterial de Muñeca Microlife Modelo BP3GK1-4B K202729Microlife Upper Arm Automatic Digital Blood Pressure Monitor

Ver todos los 18 dispositivos →

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.

Fuente oficial

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