FDA 510(k)

MoMe® ARC 電子無線行動心電圖監測與檢測系統

K 號：K230265 · 2023-10-06

決定日期2023-10-06

產品代碼DSI

諮詢委員會履歷

決定相當於

器材摘要

MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System is the device name listed in this FDA 510(k) record. The listed applicant is Infobionic, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K230265. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System?

MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Infobionic, Inc.. The 510(k) number is K230265.

When did MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System receive FDA 510(k) clearance?

MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System received FDA 510(k) clearance on 2023-10-06, under 510(k) number K230265.

Who is the listed applicant for MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System?

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

What is the FDA product code for MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System?

The FDA product code for MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System is DSI.

其他以 Infobionic, 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。

K250356MoMe ARC® 電子無線行動心電圖監測與檢測系統（32000）K160064MoMe Kardia 遊走式無線心電圖監測與檢測系統

相關器械（代碼：DSI）

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。

K243349BodyGuardian 遥測監控系統 (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® 電子無線行動心電圖監測與檢測系統（32000）Infobionic, Inc.K240177Zio AT® 裝置（A100A1001）iRhythm Technologies, Inc.K231276SmartCardia 7L 平臺Smartcardia SA K193104統一心律失常診斷系統口袋心電圖IVMedicalgorithmics S.A.K192732BodyGuardian 遥測監控系統Preventice Technologies, Inc.

官方來源

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