510(k) K180375 ยท DWJ System, Thermal Regulating
The IQoolTM Warm System
| Applicant | Braincool AB, Medicon Village, SE |
| Decision | Substantially Equivalent, May 18, 2018 |
| Received | Feb 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180375
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.