prolaio eVO2peak Module (Version 1.0) is an AI-enabled medical device from Prolaio, Inc., listed by FDA (510(k), K252204) with a decision date of 2025-12-16. Review panel: Cardiovascular.
| FDA submission number | K252204 |
|---|---|
| Pathway | 510(k) |
| Company | Prolaio, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-12-16 |
| Decision | Substantially Equivalent |
| Product code | PPW |
| Classification | Adjunctive Cardiovascular Status Indicator |
| Device class | 2 |
| Regulation number | 870.2200 |
| Review time (calendar days) | 155 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.