The following data is part of a premarket notification filed by Neuro Scan Labs with the FDA for Neuro Scan Medical Systems A4000.
| Device ID | K001562 |
| 510k Number | K001562 |
| Device Name: | NEURO SCAN MEDICAL SYSTEMS A4000 |
| Classification | Electromyograph, Diagnostic |
| Applicant | NEURO SCAN LABS 5700 CROMO DR., SUITE 100 El Paso, TX 79912 -5538 |
| Contact | David B Jones |
| Correspondent | David B Jones NEURO SCAN LABS 5700 CROMO DR., SUITE 100 El Paso, TX 79912 -5538 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-19 |
| Decision Date | 2000-08-16 |