The following data is part of a premarket notification filed by Neuromedical Systems, Inc. with the FDA for Evoked Potential System-1.0.
| Device ID | K932994 |
| 510k Number | K932994 |
| Device Name: | EVOKED POTENTIAL SYSTEM-1.0 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NEUROMEDICAL SYSTEMS, INC. 12101 COUNTY LINE RD. Chesterland, OH 44026 |
| Contact | Charles Manning |
| Correspondent | Charles Manning NEUROMEDICAL SYSTEMS, INC. 12101 COUNTY LINE RD. Chesterland, OH 44026 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-18 |
| Decision Date | 1996-04-15 |