Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Confidence Blood Glucose Monitoring System

N.º K: K173658 · 2018-08-21

SolicitanteApplied Biomedical, LLC
Fecha de decisión2018-08-21
Código de productoNBW
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

Confidence Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Biomedical, LLC. It received FDA 510(k) clearance on 2018-08-21 under 510(k) number K173658. 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.

Preguntas frecuentes

What is the Confidence Blood Glucose Monitoring System?

Confidence Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-08-21. The listed applicant is Applied Biomedical, LLC. The 510(k) number is K173658.

When did Confidence Blood Glucose Monitoring System receive FDA 510(k) clearance?

Confidence Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-08-21, under 510(k) number K173658.

Who is the listed applicant for Confidence Blood Glucose Monitoring System?

The FDA 510(k) record lists Applied Biomedical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Confidence Blood Glucose Monitoring System?

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

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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: NBW)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes CareK262116TRUE 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 CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑