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PMA de la FDA

Wearable automated external defibrillator

Número de PMA: P010030 · 2026-09-09

SolicitanteZoll Manufacturing Corporation
Fecha de decisión2026-09-09
Número PMAP010030
Código de productoMVK
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCV

Resumen del dispositivo

Wearable automated external defibrillator is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Manufacturing Corporation. It received FDA 510(k) clearance on 2026-09-09. The device is classified under product code MVK. It was reviewed by the CV advisory panel.

Preguntas frecuentes

What is the Wearable automated external defibrillator?

Wearable automated external defibrillator is a medical device that received FDA 510(k) clearance on 2026-09-09. The listed applicant is Zoll Manufacturing Corporation.

When did Wearable automated external defibrillator receive FDA 510(k) clearance?

The clearance date for Wearable automated external defibrillator can be found in the official FDA records.

Who is the listed applicant for Wearable automated external defibrillator?

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

What is the FDA product code for Wearable automated external defibrillator?

The FDA product code for Wearable automated external defibrillator is MVK.

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Fuente oficial

Ver en la base de datos de la FDA →

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