The following data is part of a premarket notification filed by Enthermics Medical Systems, Inc. with the FDA for Tru-5000 Thermal Recovery Radiant Heating Unit.
| Device ID | K963731 |
| 510k Number | K963731 |
| Device Name: | TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT |
| Classification | System, Thermal Regulating |
| Applicant | ENTHERMICS MEDICAL SYSTEMS, INC. P.O. BOX 17627 Salt Lake City, UT 84117 |
| Contact | James Dirksen |
| Correspondent | James Dirksen ENTHERMICS MEDICAL SYSTEMS, INC. P.O. BOX 17627 Salt Lake City, UT 84117 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-17 |
| Decision Date | 1997-04-22 |
| Summary: | summary |