510(k) K002577 ยท DWJ System, Thermal Regulating
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS
| Applicant | Medivance, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Oct 26, 2000 |
| Received | Aug 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002577
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2005 | MEDIVANCE INC. Arctic Sun Temperature Management System Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.