K243349 is an FDA 510(k) clearance for the BodyGuardian Remote Monitoring System (BGRMS v3.0). This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Boston Scientific Cardiac Diagnostic Technologies, Inc. (Rochester, US). The FDA issued a Cleared decision on January 23, 2026, 452 days after receiving the submission on October 28, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K243349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2024 |
| Decision Date | January 23, 2026 |
| Days to Decision | 452 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSI — Detector And Alarm, Arrhythmia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |