FDA 510(k)

Sistema de gerenciamento de diabetes Accu-Chek Guide Solo de monitoramento de glicose no sangue

Número K: K213131 · 2023-08-10

Data da decisão2023-08-10

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diabetes Care GmbH. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K213131. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Roche Diabetes Care GmbH. The 510(k) number is K213131.

When did Accu-Chek Guide Solo diabetes manager blood glucose monitoring system receive FDA 510(k) clearance?

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system received FDA 510(k) clearance on 2023-08-10, under 510(k) number K213131.

Who is the listed applicant for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

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

What is the FDA product code for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

The FDA product code for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is NBW. This falls under the OB/GYN category.

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 Roche Diabetes Care GmbH como candidato(a)

K213134Sistema de Micropompa Accu-Chek Solo com Tecnologia Interoperável

Dispositivos Relacionados (Código: NBW)

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical 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.