Warsaw, PL · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | 4 | 2025-12-11 |
| DPS | Electrocardiograph | Class II | Cardiovascular | 1 | 2024-06-20 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | Class II | Cardiovascular | 1 | 2022-06-02 |
| DSI | — | — | — | 1 | 2020-04-09 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-11 | K253141 | DeepRhythmAI | DQK | Class II | Cardiovascular |
| 2025-05-27 | K250932 | DeepRhythmAI | DQK | Class II | Cardiovascular |
| 2024-12-04 | K241197 | DeepRhythmAI | DQK | Class II | Cardiovascular |
| 2024-06-20 | K232161 | DeepRhythm Platform | DPS | Class II | Cardiovascular |
| 2022-07-27 | K210822 | DeepRhythmAI | DQK | Class II | Cardiovascular |
| 2022-06-02 | K210758 | Q Patch | MWJ | Class II | Cardiovascular |
| 2020-04-09 | K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | DSI | — | — |