510(k) K252289 ยท PMC Scalp Cooling System
Eva Scalp Cooling System
| Applicant | Stemtech Medical Devices Private Limited, Navi Mumbai, IN |
| Decision | Substantially Equivalent, Nov 25, 2025 |
| Received | Jul 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252289
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.