FDA 510(k)

WorkMate Claris 系統

K 號：K210392 · 2021-03-11

申請人Abbott

決定日期2021-03-11

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

WorkMate Claris System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2021-03-11 under 510(k) number K210392. 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 WorkMate Claris System?

WorkMate Claris System is a medical device that received FDA 510(k) clearance on 2021-03-11. The listed applicant is Abbott. The 510(k) number is K210392.

When did WorkMate Claris System receive FDA 510(k) clearance?

WorkMate Claris System received FDA 510(k) clearance on 2021-03-11, under 510(k) number K210392.

Who is the listed applicant for WorkMate Claris System?

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

What is the FDA product code for WorkMate Claris System?

The FDA product code for WorkMate Claris System is DQK.

其他以 Abbott 為申請人之記錄

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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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