Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Termômetro Infravermelho Digital Microlife Digital Infrared Forehead Thermometer, Modelo FR1MN1-1

Número K: K161728 · 2016-12-05

RequerenteMicrofile Intellectual Property GmbH
Data da decisão2016-12-05
Código do produtoFLL
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is the device name listed in this FDA 510(k) record. The listed applicant is Microfile Intellectual Property GmbH. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K161728. 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 Forehead Thermometer, Model FR1MN1-1?

Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Microfile Intellectual Property GmbH. The 510(k) number is K161728.

When did Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 receive FDA 510(k) clearance?

Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 received FDA 510(k) clearance on 2016-12-05, under 510(k) number K161728.

Who is the listed applicant for Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1?

The FDA 510(k) record lists Microfile 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 Forehead Thermometer, Model FR1MN1-1?

The FDA product code for Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: FLL)

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.

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.

↑