FDA 510(k)

AcQMap 高解析度影像與地圖系統

K 號：K210680 · 2021-08-05

決定日期2021-08-05

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

AcQMap High Resolution Imaging and Mapping System is the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K210680. 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 AcQMap High Resolution Imaging and Mapping System?

AcQMap High Resolution Imaging and Mapping System is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K210680.

When did AcQMap High Resolution Imaging and Mapping System receive FDA 510(k) clearance?

AcQMap High Resolution Imaging and Mapping System received FDA 510(k) clearance on 2021-08-05, under 510(k) number K210680.

Who is the listed applicant for AcQMap High Resolution Imaging and Mapping System?

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

What is the FDA product code for AcQMap High Resolution Imaging and Mapping System?

The FDA product code for AcQMap High Resolution Imaging and Mapping System is DQK.

其他以 Acutus Medical, Inc. 為申請人之記錄

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K233691FlexCath 過隔膜解決方案 K231091AcQMap 高解析度影像與地圖系統 K230606AcQMap® 高解析度影像與地圖系統 K222209AcQMap 高解析度影像與地圖系統 K220784AcQMap 高解析度影像與地圖系統 K210766AcQMap 3D 影像與地圖導管，型號 900009

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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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