FDA 510(k)

Zio 心電圖利用軟體（ZEUS）系統

K 號：K202527 · 2021-05-21

決定日期2021-05-21

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

Zio ECG Utilization Software (ZEUS) System is the device name listed in this FDA 510(k) record. The listed applicant is iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2021-05-21 under 510(k) number K202527. 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 Zio ECG Utilization Software (ZEUS) System?

Zio ECG Utilization Software (ZEUS) System is a medical device that received FDA 510(k) clearance on 2021-05-21. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K202527.

When did Zio ECG Utilization Software (ZEUS) System receive FDA 510(k) clearance?

Zio ECG Utilization Software (ZEUS) System received FDA 510(k) clearance on 2021-05-21, under 510(k) number K202527.

Who is the listed applicant for Zio ECG Utilization Software (ZEUS) System?

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

What is the FDA product code for Zio ECG Utilization Software (ZEUS) System?

The FDA product code for Zio ECG Utilization Software (ZEUS) System is DQK.

其他以 iRhythm Technologies, 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。

K252859ZEUS 平台 (FG0501US)K243650Zio® 監護器（DFG0001）K240177Zio AT® 裝置（A100A1001）K240029Zio AT® 裝置（A100A1001）K222389宙斯系統 K213409ZEUS 系統（Zio Watch）

查看所有 11 項裝置 →

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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