510(k) K140078 ยท DWJ System, Thermal Regulating
TECOTHERM NEO (T NEO)
| Applicant | Inspiration Healthcare, Ltd., Earl Shilton, Leicester, GB |
| Decision | Substantially Equivalent, Nov 14, 2014 |
| Received | Jan 13, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K140078
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2018 | Tec Com Gmbh TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.