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FDA PMA

Wearable automated external defibrillator

Número do PMA: P010030 · 2026-09-09

RequerenteZoll Manufacturing Corporation
Data da decisão2026-09-09
Número PMAP010030
Código do produtoMVK
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCV

Resumo do 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.

Perguntas frequentes

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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Fonte oficial

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