FDA 510(k)

Microlife Non-Contact Infrared Forehead Thermometer

Número K: K191829 · 2020-02-13

RequerenteMicrolife Intellectual Property GmbH

Data da decisão2020-02-13

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Microlife Non-Contact Infrared Forehead 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 2020-02-13 under 510(k) number K191829. 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 Non-Contact Infrared Forehead Thermometer?

Microlife Non-Contact Infrared Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K191829.

When did Microlife Non-Contact Infrared Forehead Thermometer receive FDA 510(k) clearance?

Microlife Non-Contact Infrared Forehead Thermometer received FDA 510(k) clearance on 2020-02-13, under 510(k) number K191829.

Who is the listed applicant for Microlife Non-Contact Infrared Forehead 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 Non-Contact Infrared Forehead Thermometer?

The FDA product code for Microlife Non-Contact Infrared Forehead Thermometer is FLL.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Microlife Intellectual Property GmbH como candidato(a)

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 Pressão Arterial de Pulso Microlife Modelo BP3GK1-4B K202729Microlife Upper Arm Automatic Digital Blood Pressure Monitor

Ver todos os 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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.