510(k) K260278 ยท DWJ System, Thermal Regulating
ThermAffyx(TM) Patient Safety System
| Applicant | Stihler Electronic GmbH, Leinfelden-Echterdingen, DE |
| Decision | Substantially Equivalent, Jul 8, 2026 |
| Received | Jan 29, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260278
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.