DSI — Detector And Alarm, Arrhythmia Class II
FDA product code DSI covers "Detector And Alarm, Arrhythmia", a Class II medical device regulated under 21 CFR 870.1025. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DSI
- Device Class
- Class II
- Regulation Number
- 870.1025
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243349 | boston scientific cardiac diagnostic technologies | BodyGuardian Remote Monitoring System (BGRMS v3.0) | January 23, 2026 |
| K250356 | infobionic | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | July 29, 2025 |
| K240177 | irhythm technologies | Zio AT® device (A100A1001) | October 30, 2024 |
| K230265 | infobionic | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | October 6, 2023 |
| K231276 | smartcardia | SmartCardia 7L Platform | August 30, 2023 |
| K193104 | medicalgorithmics | Unified Arrhythmia Diagnostic System PocketECG IV | April 9, 2020 |
| K192732 | preventice technologies | BodyGuardian Remote Monitoring System | March 26, 2020 |
| K190574 | medtronic | Patient Assistant Model PA97000 | September 24, 2019 |
| K182532 | national cardiac | Liba3 System | May 15, 2019 |
| K181658 | memtec corporation | MobileECG 2 BT | March 26, 2019 |
| K173969 | medicalgorithmics | Medicalgorithmics Unified Cardiac Rehabilitation System | July 11, 2018 |
| K173170 | medicomp | Epicardia Anywhere | January 10, 2018 |
| K153473 | braemar manufacturing | Braemar Telemetry Patch System | July 22, 2016 |
| K153477 | vitasystems | EMMa Electronic Monitoring Management | May 25, 2016 |
| K152701 | global instrumentation | Matrix Mini ECG Monitor | April 22, 2016 |
| K152305 | nihon kohden corporation | Nihon Kohden Afib Detection Program QP-039P | April 8, 2016 |
| K151835 | lifewatch technologies | Vital Signs Patch System | February 5, 2016 |
| K151269 | lifewatch technologies | ECG Mini System Continuous ECG Monitor and Arrhythmia Detector | January 15, 2016 |
| K152491 | infobionic | MoMe Software Platform | December 17, 2015 |
| K152550 | medicalgorithmics | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM | October 8, 2015 |