The following data is part of a premarket notification filed by Neurosoft, Inc. with the FDA for Neurosoft's Source.
| Device ID | K011241 |
| 510k Number | K011241 |
| Device Name: | NEUROSOFT'S SOURCE |
| Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Applicant | NEUROSOFT, INC. 5700 CROMO, SUITE 100 El Paso, TX 79912 |
| Contact | Elvira Garcia |
| Correspondent | Elvira Garcia NEUROSOFT, INC. 5700 CROMO, SUITE 100 El Paso, TX 79912 |
| Product Code | OLX |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-23 |
| Decision Date | 2001-09-19 |