The following data is part of a premarket notification filed by Medoc Ltd. Advanced Medical Systems with the FDA for Modified Contact-heat Evoked Potential Stimulator (cheps).
| Device ID | K051448 |
| 510k Number | K051448 |
| Device Name: | MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) |
| Classification | Evoked Potential Stimulator, Thermal |
| Applicant | MEDOC LTD. ADVANCED MEDICAL SYSTEMS 291 Hillside Avenue Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub MEDOC LTD. ADVANCED MEDICAL SYSTEMS 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | NTU |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-02 |
| Decision Date | 2005-06-29 |
| Summary: | summary |