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FDA 510(k)

EnSite Velocity 心臟映射系統 v5.2，EnSite Precision 心臟映射系統 v2.2

K 號：K182644 · 2018-10-19

申請人Abbott
決定日期2018-10-19
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 v5.2, EnSite Precision Cardiac Mapping System v2.2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2018-10-19 under 510(k) number K182644. 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 v5.2, EnSite Precision Cardiac Mapping System v2.2?

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 is a medical device that received FDA 510(k) clearance on 2018-10-19. The listed applicant is Abbott. The 510(k) number is K182644.

When did EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 receive FDA 510(k) clearance?

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 received FDA 510(k) clearance on 2018-10-19, under 510(k) number K182644.

Who is the listed applicant for EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2?

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 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2?

The FDA product code for EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 is DQK.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Abbott 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。

K261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管K260993Amplatzer TorqVue 遞送系統K251221Assert-IQ (DM5000)；Assert-IQ (DM5300)；Assert-IQ (DM5500)；Merlin.net (MN7000)K233655醫療設備名稱：Lingo血糖系統K222297CentriMag 預連接包K221213EnSite X EP 系統

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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 MedicalK262005Affera 整合地圖系統Medtronic, Inc.K253692AVVIGO™+ 多模態導引系統Boston ScientificK253576CorVista System® 內建 PCWP 附加功能Analytics For Life, Inc.K262006EnSite™ X EP 系統Abbott MedicalK252978ScioCardio 心電圖分析平台Synergen Technology Labs, LLC

官方來源

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