DSI — Detector And Alarm, Arrhythmia Class II
FDA Device Classification
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 |