FDA 510(k)

ILR 心電圖分析儀 (IM007)

K 號：K253463 · 2026-07-02

決定日期2026-07-02

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

ILR ECG Analyzer (IM007) is the device name listed in this FDA 510(k) record. The listed applicant is Implicity, Inc.. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K253463. 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 ILR ECG Analyzer (IM007)?

ILR ECG Analyzer (IM007) is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Implicity, Inc.. The 510(k) number is K253463.

When did ILR ECG Analyzer (IM007) receive FDA 510(k) clearance?

ILR ECG Analyzer (IM007) received FDA 510(k) clearance on 2026-07-02, under 510(k) number K253463.

Who is the listed applicant for ILR ECG Analyzer (IM007)?

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

What is the FDA product code for ILR ECG Analyzer (IM007)?

The FDA product code for ILR ECG Analyzer (IM007) is DQK.

其他以 Implicity, Inc. 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。

K230842SignalHF (IM008)K210543IM007

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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