510(k) K200225 ยท DWJ System, Thermal Regulating
Arctic Sun Stat Temperature Management System
| Applicant | Medivance, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Feb 28, 2020 |
| Received | Jan 30, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200225
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2024 | Medivance Inc. Arctic Sun Temperature Management Systems, Name/REF:
Arctic Sun STAT, NA/6000-00-00;
Arctic Sun STAT Loaner, NA/6000-00-00L;
Arctic Sun Stat EU UK/600001;
Arctic Sun Stat Taiwan/600006;
Arctic Sun St Open, Classified |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.