510(k) K101092 ยท DWJ System, Thermal Regulating
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
| Applicant | Medivance, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Jul 16, 2010 |
| Received | Apr 20, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101092
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2017 | C.R. Bard, Inc. Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US Terminated |
DWJ | None listed |
| May 6, 2016 | C.R. Bard, Inc. Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V
The product is a thermal regulating system indicated for monitoring and controlling patient temperature Terminated |
DWJ | None listed |
| 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.