510(k) K243942 ยท DWJ System, Thermal Regulating
Arctic Sun Stat Temperature Management System
| Applicant | Medivance, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Apr 30, 2025 |
| Received | Dec 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243942
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.