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510(k) K243349

BodyGuardian Remote Monitoring System (BGRMS v3.0) by Boston Scientific Cardiac Diagnostic Technologies, Inc. — Product Code DSI

K243349 is an FDA 510(k) premarket notification submitted by Boston Scientific Cardiac Diagnostic Technologies, Inc. for the device "BodyGuardian Remote Monitoring System (BGRMS v3.0)". The FDA issued a decision of Substantially Equivalent on January 23, 2026. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2026
Date Received
October 28, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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  • K231276 — SmartCardia 7L Platform (August 30, 2023)
  • K193104 — Unified Arrhythmia Diagnostic System PocketECG IV (April 9, 2020)
  • K192732 — BodyGuardian Remote Monitoring System (March 26, 2020)
  • K190574 — Patient Assistant Model PA97000 (September 24, 2019)
  • K182532 — Liba3 System (May 15, 2019)
  • K181658 — MobileECG 2 BT (March 26, 2019)
  • K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System (July 11, 2018)

FDA data resources