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

Gastric Emptying Breath Test

Número de PMA: P110015 · 2026-04-24

SolicitanteAdvanced Breath Diagnostics
Fecha de decisión2026-04-24
Número PMAP110015
Código de productoPGE
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCH

Resumen del dispositivo

Gastric Emptying Breath Test is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Breath Diagnostics. It received FDA 510(k) clearance on 2026-04-24. The device is classified under product code PGE. It was reviewed by the CH advisory panel.

Preguntas frecuentes

What is the Gastric Emptying Breath Test?

Gastric Emptying Breath Test is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Advanced Breath Diagnostics.

When did Gastric Emptying Breath Test receive FDA 510(k) clearance?

The clearance date for Gastric Emptying Breath Test can be found in the official FDA records.

Who is the listed applicant for Gastric Emptying Breath Test?

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

What is the FDA product code for Gastric Emptying Breath Test?

The FDA product code for Gastric Emptying Breath Test is PGE.

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.

↑