The following data is part of a premarket notification filed by Elekta Neuromag Oy with the FDA for Elekta Oy.
| Device ID | K041264 |
| 510k Number | K041264 |
| Device Name: | ELEKTA OY |
| Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Applicant | ELEKTA NEUROMAG OY ELIMAENKATU 22 B, PO BX 68 Helsinki, FI Fin-00511 |
| Contact | Birgitta Fagerstrom |
| Correspondent | Birgitta Fagerstrom ELEKTA NEUROMAG OY ELIMAENKATU 22 B, PO BX 68 Helsinki, FI Fin-00511 |
| Product Code | OLX |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OLY |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-12 |
| Decision Date | 2004-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430056480350 | K041264 | 000 |
| 06430056480336 | K041264 | 000 |
| 06430056480329 | K041264 | 000 |
| 06430056480312 | K041264 | 000 |
| 06430056480305 | K041264 | 000 |
| 06430056480299 | K041264 | 000 |