The following data is part of a premarket notification filed by Neurosoft, Inc. with the FDA for Neuro Scan Medical Ststems, Model Medicor 8.
| Device ID | K001692 |
| 510k Number | K001692 |
| Device Name: | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | NEUROSOFT, INC. 5700 CROMO, SUITE 100 El Paso, TX 79912 |
| Contact | David B Jones |
| Correspondent | David B Jones NEUROSOFT, INC. 5700 CROMO, SUITE 100 El Paso, TX 79912 |
| Product Code | JXE |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | IKN |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-02 |
| Decision Date | 2000-11-24 |