FDA 510(k)

CONTOUR® NEXT ONE Blood Glucose Monitoring System

Numéro K : K210687 · 2021-08-11

Date de décision2021-08-11

Code produitNBW

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

CONTOUR® NEXT ONE Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Ascensia Diabetes Care. It received FDA 510(k) clearance on 2021-08-11 under 510(k) number K210687. 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.

Questions fréquentes

What is the CONTOUR® NEXT ONE Blood Glucose Monitoring System?

CONTOUR® NEXT ONE Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2021-08-11. The listed applicant is Ascensia Diabetes Care. The 510(k) number is K210687.

When did CONTOUR® NEXT ONE Blood Glucose Monitoring System receive FDA 510(k) clearance?

CONTOUR® NEXT ONE Blood Glucose Monitoring System received FDA 510(k) clearance on 2021-08-11, under 510(k) number K210687.

Who is the listed applicant for CONTOUR® NEXT ONE Blood Glucose Monitoring System?

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

What is the FDA product code for CONTOUR® NEXT ONE Blood Glucose Monitoring System?

The FDA product code for CONTOUR® NEXT ONE Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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

Autres dossiers indiquant Ascensia Diabetes Care en tant que demandeur

Dispositifs connexes (Code : 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.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.