Boston, MA, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PPW | Adjunctive Cardiovascular Status Indicator | Class II | Cardiovascular | 4 | 2026-04-03 |
| PLB | Multivariate Vital Signs Index | Class II | Cardiovascular | 1 | 2023-01-06 |
| MWI | — | — | — | 1 | 2020-11-25 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-03 | K254066 | Etiometry Platform | PPW | Class II | Cardiovascular |
| 2025-02-12 | K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | PPW | Class II | Cardiovascular |
| 2023-07-07 | K223578 | T3 Platform software | PPW | Class II | Cardiovascular |
| 2023-01-06 | K213423 | T3 Platform software | PLB | Class II | Cardiovascular |
| 2022-06-22 | K213230 | T3 Platform Software | PPW | Class II | Cardiovascular |
| 2020-11-25 | K202306 | T3 Platform software | MWI | — | — |