The following data is part of a premarket notification filed by Medoc Ltd. Advanced Medical Systems with the FDA for Contact Heat-evoked Potential Stimulator (cheps).
| Device ID | K041908 |
| 510k Number | K041908 |
| Device Name: | CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) |
| Classification | Evoked Potential Stimulator, Thermal |
| Applicant | MEDOC LTD. ADVANCED MEDICAL SYSTEMS 4050 OLSON MEMORIAL HIGHWAY SUITE 350 Minneapolis, MN 55422 |
| Contact | Tracy Gray |
| Correspondent | Tracy Gray MEDOC LTD. ADVANCED MEDICAL SYSTEMS 4050 OLSON MEMORIAL HIGHWAY SUITE 350 Minneapolis, MN 55422 |
| Product Code | NTU |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-15 |
| Decision Date | 2005-02-25 |
| Summary: | summary |