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 |