510(k) K071341 ยท DWJ System, Thermal Regulating
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
| Applicant | Medivance, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Aug 3, 2007 |
| Received | May 14, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071341
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2016 | C.R. Bard, Inc. Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures. Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.