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FDA PMA

穿戴式自動外部除颤器

PMA 核准號:P010030 · 2026-09-09

決定日期2026-09-09
PMA 編號P010030
產品代碼MVK
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

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.

常見問題

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.

誰是可攜式自動外用除颤器的登記申請人?

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

FDA產品代碼是什麼?可攜式自動外用除颤器?

FDA產品代碼,對於可攜式自動外用除颤器為MVK。

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官方來源

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