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)

Fungitell STAT

N.º K: K191167 · 2019-07-17

SolicitanteAssociates of Cape Cod, Inc.
Fecha de decisión2019-07-17
Código de productoNQZ
Comité asesorMI
DecisiónSubstantially Equivalent

Resumen del dispositivo

Fungitell STAT is the device name listed in this FDA 510(k) record. The listed applicant is Associates of Cape Cod, Inc.. It received FDA 510(k) clearance on 2019-07-17 under 510(k) number K191167. The device is classified under product code NQZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Fungitell STAT?

Fungitell STAT is a medical device that received FDA 510(k) clearance on 2019-07-17. The listed applicant is Associates of Cape Cod, Inc.. The 510(k) number is K191167.

When did Fungitell STAT receive FDA 510(k) clearance?

Fungitell STAT received FDA 510(k) clearance on 2019-07-17, under 510(k) number K191167.

Who is the listed applicant for Fungitell STAT?

The FDA 510(k) record lists Associates of Cape Cod, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fungitell STAT?

The FDA product code for Fungitell STAT is NQZ.

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.

↑