The following data is part of a premarket notification filed by Elekta Neuromag Oy with the FDA for Elekta Neuromag With Maxwell Filter.
| Device ID | K050035 |
| 510k Number | K050035 |
| Device Name: | ELEKTA NEUROMAG WITH MAXWELL FILTER |
| Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Applicant | ELEKTA NEUROMAG OY KUNGSTENSGATAN 18 PO BOX 7593 Stockholm, SE Se-103 93 |
| Contact | Louise Lindblad |
| Correspondent | Louise Lindblad ELEKTA NEUROMAG OY KUNGSTENSGATAN 18 PO BOX 7593 Stockholm, SE Se-103 93 |
| Product Code | OLX |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OLY |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-07 |
| Decision Date | 2005-01-25 |
| Summary: | summary |