FDA 510(k)

節律視工作站

K 號：K171583 · 2017-09-01

決定日期2017-09-01

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

RhythmView Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Electrophysiology. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K171583. 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 RhythmView Workstation?

RhythmView Workstation is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is Abbott Electrophysiology. The 510(k) number is K171583.

When did RhythmView Workstation receive FDA 510(k) clearance?

RhythmView Workstation received FDA 510(k) clearance on 2017-09-01, under 510(k) number K171583.

Who is the listed applicant for RhythmView Workstation?

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

What is the FDA product code for RhythmView Workstation?

The FDA product code for RhythmView Workstation is DQK.

其他以 Abbott Electrophysiology 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。

K163709FIRMap 穿刺針 K161240節奏視覺工作站（非串流）K153093FIRMap 穿刺針

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。