510(k) K261437 · DWJ System, Thermal Regulating
Mistral-Air® Warming System
| Applicant | The Surgical Company International B.V., doing business as TSC Life, Amsterdam, NL |
| Decision | Substantially Equivalent, Aug 7, 2026 |
| Received | Apr 30, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261437
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.