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.

PMA de la FDA

Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated

Número de PMA: P160030 · 2026-09-01

SolicitanteAbbott Diabetes Care, Inc.
Fecha de decisión2026-09-01
Número PMAP160030
Código de productoPZE
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCH

Resumen del dispositivo

Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated 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 2026-09-01. The device is classified under product code PZE. It was reviewed by the CH advisory panel.

Preguntas frecuentes

What is the Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated?

Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Abbott Diabetes Care, Inc..

When did Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated receive FDA 510(k) clearance?

The clearance date for Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated can be found in the official FDA records.

Who is the listed applicant for Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated?

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 Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated?

The FDA product code for Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated is PZE.

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

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.

↑