FDA 510(k)

VX1+

K 號：K223516 · 2023-01-21

決定日期2023-01-21

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

VX1+ is the device name listed in this FDA 510(k) record. The listed applicant is Volta Medical. It received FDA 510(k) clearance on 2023-01-21 under 510(k) number K223516. 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 VX1+?

VX1+ is a medical device that received FDA 510(k) clearance on 2023-01-21. The listed applicant is Volta Medical. The 510(k) number is K223516.

When did VX1+ receive FDA 510(k) clearance?

VX1+ received FDA 510(k) clearance on 2023-01-21, under 510(k) number K223516.

Who is the listed applicant for VX1+?

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 VX1+?

The FDA product code for VX1+ 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 K243812伏打AF-Xplorer K232616伏打AF-Xplorer 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。

K261729EnSite™ X EP 系統Abbott Medical K262005Affera 整合地圖系統Medtronic, Inc.K253692AVVIGO™+ 多模態導引系統Boston Scientific K253576CorVista System® 內建 PCWP 附加功能Analytics For Life, Inc.K262006EnSite™ X EP 系統Abbott Medical K252978ScioCardio 心電圖分析平台Synergen Technology Labs, LLC

官方來源

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