510(k) K083662 ยท DWJ System, Thermal Regulating
CRITICOOL
| Applicant | Mtre Advanced Technology , Ltd., Yavne, IL |
| Decision | Substantially Equivalent, Mar 26, 2009 |
| Received | Dec 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083662
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2022 | Belmont Instrument Corporation CritiCool, thermoregulation device Open, Classified |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.