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)

QuickSleeper 5

N.º K: K243427 · 2025-08-01

SolicitanteDentalhitec
Fecha de decisión2025-08-01
Código de productoEGM
Comité asesorDE
DecisiónSubstantially Equivalent

Resumen del dispositivo

QuickSleeper 5 is the device name listed in this FDA 510(k) record. The listed applicant is Dentalhitec. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K243427. The device is classified under product code EGM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the QuickSleeper 5?

QuickSleeper 5 is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is Dentalhitec. The 510(k) number is K243427.

When did QuickSleeper 5 receive FDA 510(k) clearance?

QuickSleeper 5 received FDA 510(k) clearance on 2025-08-01, under 510(k) number K243427.

Who is the listed applicant for QuickSleeper 5?

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

What is the FDA product code for QuickSleeper 5?

The FDA product code for QuickSleeper 5 is EGM.

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.

↑