K243349
- 510(k) number
- K243349
- Device name
- BodyGuardian Remote Monitoring System (BGRMS v3.0)
- Applicant
- Boston Scientific Cardiac Diagnostic Technologies, Inc. MN · US
- Product code
- DSI — Detector And Alarm, Arrhythmia
- Decision date
- 2026-01-23
- Date received
- 2024-10-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243349.pdf
Official FDA record: K243349
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.