510(k) K254066 ยท PPW Adjunctive Cardiovascular Status Indicator
Etiometry Platform
| Applicant | Etiometry, Inc., Dedham MA, US |
| Decision | Substantially Equivalent, Apr 3, 2026 |
| Received | Dec 18, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254066
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.