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)

MeRT System

N.º K: K260402 · 2026-06-03

SolicitanteWave Neuroscience
Fecha de decisión2026-06-03
Código de productoSIG
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

MeRT System is the device name listed in this FDA 510(k) record. The listed applicant is Wave Neuroscience. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K260402. The device is classified under product code SIG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MeRT System?

MeRT System is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Wave Neuroscience. The 510(k) number is K260402.

When did MeRT System receive FDA 510(k) clearance?

MeRT System received FDA 510(k) clearance on 2026-06-03, under 510(k) number K260402.

Who is the listed applicant for MeRT System?

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

What is the FDA product code for MeRT System?

The FDA product code for MeRT System is SIG.

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.

↑