FDA 510(k)

伏打AF-Xplorer

K 號：K243812 · 2025-05-09

決定日期2025-05-09

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

Volta AF-Xplorer is the device name listed in this FDA 510(k) record. The listed applicant is Volta Medical. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K243812. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Volta AF-Xplorer?

Volta AF-Xplorer is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Volta Medical. The 510(k) number is K243812.

When did Volta AF-Xplorer receive FDA 510(k) clearance?

Volta AF-Xplorer received FDA 510(k) clearance on 2025-05-09, under 510(k) number K243812.

Who is the listed applicant for Volta AF-Xplorer?

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

What is the FDA product code for Volta AF-Xplorer?

The FDA product code for Volta AF-Xplorer is DQK.

其他以 Volta Medical 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251518伏打AF-Xplorer II K232616伏打AF-Xplorer K223516VX1+K201298VX1

相關器械（代碼：DQK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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