The following data is part of a premarket notification filed by Neuro Scan Labs with the FDA for Scan Lt40 (40 Channels).
| Device ID | K001564 |
| 510k Number | K001564 |
| Device Name: | SCAN LT40 (40 CHANNELS) |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| 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 | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-19 |
| Decision Date | 2000-11-24 |