FDA 510(k)

BodyGuardian 遥測監控系統 (BGRMS v3.0)

K 號：K243349 · 2026-01-23

申請人Boston Scientific Cardiac Diagnostic Technologies, Inc.

決定日期2026-01-23

產品代碼DSI

諮詢委員會履歷

決定相當於

器材摘要

BodyGuardian Remote Monitoring System (BGRMS v3.0) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Cardiac Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 2026-01-23 under 510(k) number K243349. 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 BodyGuardian Remote Monitoring System (BGRMS v3.0)?

BodyGuardian Remote Monitoring System (BGRMS v3.0) is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Boston Scientific Cardiac Diagnostic Technologies, Inc.. The 510(k) number is K243349.

When did BodyGuardian Remote Monitoring System (BGRMS v3.0) receive FDA 510(k) clearance?

BodyGuardian Remote Monitoring System (BGRMS v3.0) received FDA 510(k) clearance on 2026-01-23, under 510(k) number K243349.

Who is the listed applicant for BodyGuardian Remote Monitoring System (BGRMS v3.0)?

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

What is the FDA product code for BodyGuardian Remote Monitoring System (BGRMS v3.0)?

The FDA product code for BodyGuardian Remote Monitoring System (BGRMS v3.0) is DSI.

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。

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 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

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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：DSI）

官方來源