510(k) K263587 · DWJ System, Thermal Regulating
Arctic Sun Neonatal ArcticGel Pad
| Applicant | Medivance, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Oct 30, 2026 |
| Received | Sep 30, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K263587
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.