FDA 510(k)

VX1

K 號：K201298 · 2020-09-16

決定日期2020-09-16

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 2020-09-16 under 510(k) number K201298. 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 2020-09-16. The listed applicant is Volta Medical. The 510(k) number is K201298.

When did VX1 receive FDA 510(k) clearance?

VX1 received FDA 510(k) clearance on 2020-09-16, under 510(k) number K201298.

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 K223516VX1+

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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