DSI
- Product code
- DSI
- Device name
- Detector And Alarm, Arrhythmia
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1025
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 398 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243349 | 2026-01-23 | Boston Scientific Cardiac Diagnostic T… | BodyGuardian Remote Monitoring System (BGRMS v3.0) | |
| K250356 | 2025-07-29 | Infobionic, Inc. | MoMe ARC® Wireless Ambulatory ECG Monitoring and Det… | FDA |
| K240177 | 2024-10-30 | iRhythm Technologies, Inc. | Zio AT® device (A100A1001) | |
| K230265 | 2023-10-06 | Infobionic, Inc. | MoMe® ARC Wireless Ambulatory ECG Monitoring and Det… |
Official FDA classification page: DSI
Classification and pathway per current FDA publications. Data from openFDA (CC0).