FDA 510(k)

ZEUS 系統（Zio Watch）

K 號：K213409 · 2022-07-19

決定日期2022-07-19

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

ZEUS System (Zio Watch) 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 2022-07-19 under 510(k) number K213409. 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 ZEUS System (Zio Watch)?

ZEUS System (Zio Watch) is a medical device that received FDA 510(k) clearance on 2022-07-19. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K213409.

When did ZEUS System (Zio Watch) receive FDA 510(k) clearance?

ZEUS System (Zio Watch) received FDA 510(k) clearance on 2022-07-19, under 510(k) number K213409.

Who is the listed applicant for ZEUS System (Zio Watch)?

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 ZEUS System (Zio Watch)?

The FDA product code for ZEUS System (Zio Watch) 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 K202359Zio 監控器

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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