FDA 510(k)

Ensite Velocity 心臟電位圖系統 v5.0，Ensite Automap 模組 v1.0

K 號：K160187 · 2016-10-21

決定日期2016-10-21

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K160187. 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 Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0?

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is St Jude Medical. The 510(k) number is K160187.

When did Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 receive FDA 510(k) clearance?

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 received FDA 510(k) clearance on 2016-10-21, under 510(k) number K160187.

Who is the listed applicant for Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0?

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

What is the FDA product code for Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0?

The FDA product code for Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 is DQK.

其他以 St Jude 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。

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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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