510(k) K180834 ยท DWJ System, Thermal Regulating
Altrix Precision Temperature Management System
| Applicant | Stryker Medical, Portage MI, US |
| Decision | Substantially Equivalent, Aug 10, 2018 |
| Received | Mar 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180834
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2018 | Stryker Medical Division of Stryker Corporation Altrix Precision Temperature Management System
Model: 8001Product Usage:
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer de Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.