FDA 510(k)

CareSens S Fit Blood Glucose Monitoring System

Número K: K180866 · 2018-08-31

Data da decisão2018-08-31

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

CareSens S Fit Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is I-Sens, Inc.. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K180866. 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 CareSens S Fit Blood Glucose Monitoring System?

CareSens S Fit Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is I-Sens, Inc.. The 510(k) number is K180866.

When did CareSens S Fit Blood Glucose Monitoring System receive FDA 510(k) clearance?

CareSens S Fit Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-08-31, under 510(k) number K180866.

Who is the listed applicant for CareSens S Fit Blood Glucose Monitoring System?

The FDA 510(k) record lists I-Sens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CareSens S Fit Blood Glucose Monitoring System?

The FDA product code for CareSens S Fit 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 I-Sens, Inc. como candidato(a)

K230625ReliOn Premier BLU Blood Glucose Monitoring System K222656LDE4 Lancing Device K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System K201551KetoSens BT Blood B-Ketone Monitoring System K192859CareSens S Clear BT Blood Glucose Monitoring System K193590Sistema de Monitoramento de Glicemia CareSens S Fit BT

Ver todos os 13 dispositivos →

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.