免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

MobileECG 2 BT

K 號：K181658 · 2019-03-26

申請人Memtec Corporation
決定日期2019-03-26
產品代碼DSI
諮詢委員會履歷
決定相當於

器材摘要

MobileECG 2 BT is the device name listed in this FDA 510(k) record. The listed applicant is Memtec Corporation. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K181658. 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 MobileECG 2 BT?

MobileECG 2 BT is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Memtec Corporation. The 510(k) number is K181658.

When did MobileECG 2 BT receive FDA 510(k) clearance?

MobileECG 2 BT received FDA 510(k) clearance on 2019-03-26, under 510(k) number K181658.

Who is the listed applicant for MobileECG 2 BT?

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

What is the FDA product code for MobileECG 2 BT?

The FDA product code for MobileECG 2 BT is DSI.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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.K230265MoMe® ARC 電子無線行動心電圖監測與檢測系統Infobionic, Inc.K231276SmartCardia 7L 平臺Smartcardia SAK193104統一心律失常診斷系統口袋心電圖IVMedicalgorithmics S.A.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑