The following data is part of a premarket notification filed by Neurosoft, Inc. with the FDA for Neuro Scan Medical Systems, Models 302l Medicor (laboratory) And 302p Advantage 3000 (portable).
| Device ID | K000812 |
| 510k Number | K000812 |
| Device Name: | NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) |
| Classification | Electromyograph, Diagnostic |
| Applicant | NEUROSOFT, INC. 5700 CROMO DR. SUITE 100 El Paso, TX 79912 |
| Contact | David B Jones |
| Correspondent | David B Jones NEUROSOFT, INC. 5700 CROMO DR. SUITE 100 El Paso, TX 79912 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-13 |
| Decision Date | 2000-05-17 |