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FDA PMA

刺激器,低電場,腫瘤治療

PMA 核准號:P100034 · 2026-09-18

決定日期2026-09-18
PMA 編號P100034
產品代碼NZK
器械分類3 類
醫療專科U
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)

器材摘要

Stimulator, low electric field, tumor treatment is the device name listed in this FDA 510(k) record. The listed applicant is Novocure, GmbH. It received FDA 510(k) clearance on 2026-09-18. The device is classified under product code NZK. It was reviewed by the NE advisory panel.

常見問題

What is the Stimulator, low electric field, tumor treatment?

Stimulator, low electric field, tumor treatment is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Novocure, GmbH.

When did Stimulator, low electric field, tumor treatment receive FDA 510(k) clearance?

The clearance date for Stimulator, low electric field, tumor treatment can be found in the official FDA records.

誰是低電場腫瘤治療刺激器的列名申請人?

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

FDA產品代碼為何是Stimulator, 低電場, 癌症治療?

FDA產品代碼為Stimulator,低電場,腫瘤治療的產品為NZK。

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官方來源

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