FDA 510(k)

IM007

K 號：K210543 · 2021-11-03

決定日期2021-11-03

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

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 2021-11-03 under 510(k) number K210543. 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 IM007?

IM007 is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is Implicity, Inc.. The 510(k) number is K210543.

When did IM007 receive FDA 510(k) clearance?

IM007 received FDA 510(k) clearance on 2021-11-03, under 510(k) number K210543.

Who is the listed applicant for 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 IM007?

The FDA product code for 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。

K253463ILR 心電圖分析儀 (IM007)K230842SignalHF (IM008)

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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