The following data is part of a premarket notification filed by Elekta Neuromag Oy with the FDA for Elekta Neuromag With Maxwell Filter With Internal Active Shielding.
| Device ID | K081430 |
| 510k Number | K081430 |
| Device Name: | ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING |
| Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Applicant | ELEKTA NEUROMAG OY P.O. BOX 68 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm ELEKTA NEUROMAG OY P.O. BOX 68 Deerfield, IL 60015 |
| 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 | 2008-05-21 |
| Decision Date | 2008-07-28 |
| Summary: | summary |