The following data is part of a premarket notification filed by Inspiration Healthcare Ltd with the FDA for Tecotherm Neo (t Neo).
| Device ID | K140078 |
| 510k Number | K140078 |
| Device Name: | TECOTHERM NEO (T NEO) |
| Classification | System, Thermal Regulating |
| Applicant | INSPIRATION HEALTHCARE LTD GILDOR HOUSE, WEST STREET Earl Shilton, Leicester, GB Le9 7ej |
| Contact | Wayne Iddon |
| Correspondent | Wayne Iddon INSPIRATION HEALTHCARE LTD GILDOR HOUSE, WEST STREET Earl Shilton, Leicester, GB Le9 7ej |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-13 |
| Decision Date | 2014-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260647540314 | K140078 | 000 |