FDA 510(k)

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

Número K: K201761 · 2021-07-30

Data da decisão2021-07-30

Código do produtoQLG

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K201761. The device is classified under product code QLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K201761.

When did FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) receive FDA 510(k) clearance?

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) received FDA 510(k) clearance on 2021-07-30, under 510(k) number K201761.

Who is the listed applicant for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

The FDA 510(k) record lists Abbott Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

The FDA product code for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is QLG.

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 Abbott Diabetes Care, Inc. como candidato(a)

K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System K223537FreeStyle Libre 2 System, FreeStyle Libre 3 System K213996FreeStyle Libre 3 Continuous Glucose Monitoring System K212132FreeStyle Libre 3 Continuous Glucose Monitoring System

Ver todos os 12 dispositivos →

Dispositivos Relacionados (Código: QLG)

K222280Bigfoot Unity® Diabetes Management SystemBigfoot Biomedical, Inc.K223537FreeStyle Libre 2 System, FreeStyle Libre 3 SystemAbbott Diabetes Care, Inc.K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc.K211102FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.

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.