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PMA de la FDA

Detector de eventos de síndrome coronario agudo

Número de PMA: P150009 · 2024-08-14

SolicitanteAvertix Medical, Inc.
Fecha de decisión2024-08-14
Número PMAP150009
Código de productoQBI
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCV

Resumen del dispositivo

Acute coronary syndrome event detector is the device name listed in this FDA 510(k) record. The listed applicant is Avertix Medical, Inc.. It received FDA 510(k) clearance on 2024-08-14. The device is classified under product code QBI. It was reviewed by the CV advisory panel.

Preguntas frecuentes

What is the Acute coronary syndrome event detector?

Acute coronary syndrome event detector is a medical device that received FDA 510(k) clearance on 2024-08-14. The listed applicant is Avertix Medical, Inc..

When did Acute coronary syndrome event detector receive FDA 510(k) clearance?

The clearance date for Acute coronary syndrome event detector can be found in the official FDA records.

Who is the listed applicant for Acute coronary syndrome event detector?

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

What is the FDA product code for Acute coronary syndrome event detector?

The FDA product code for Acute coronary syndrome event detector is QBI.

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Fuente oficial

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