510(k) K252204 ยท PPW Adjunctive Cardiovascular Status Indicator
prolaio eVO2peak Module (Version 1.0)
| Applicant | Prolaio, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Dec 16, 2025 |
| Received | Jul 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252204
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.