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510(k) K243349

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

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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