The following data is part of a premarket notification filed by Elekta Neuromag Oy with the FDA for Elekta Neuromag With Maxfilter.
| Device ID | K091393 |
| 510k Number | K091393 |
| Device Name: | ELEKTA NEUROMAG WITH MAXFILTER |
| Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Applicant | ELEKTA NEUROMAG OY 8726 FERRARA CT. Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm ELEKTA NEUROMAG OY 8726 FERRARA CT. Naples, FL 34114 |
| Product Code | OLX |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-11 |
| Decision Date | 2010-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430056480398 | K091393 | 000 |
| 06430056480190 | K091393 | 000 |
| 06430056480107 | K091393 | 000 |
| 06430056480091 | K091393 | 000 |
| 06430056480084 | K091393 | 000 |
| 06430056480077 | K091393 | 000 |
| 06430056480060 | K091393 | 000 |
| 06430056480053 | K091393 | 000 |
| 06430056480046 | K091393 | 000 |
| 06430056480022 | K091393 | 000 |
| 06430056480015 | K091393 | 000 |
| 06430056480121 | K091393 | 000 |
| 06430056480138 | K091393 | 000 |
| 06430056480381 | K091393 | 000 |
| 06430056480374 | K091393 | 000 |
| 06430056480367 | K091393 | 000 |
| 06430056480282 | K091393 | 000 |
| 06430056480275 | K091393 | 000 |
| 06430056480183 | K091393 | 000 |
| 06430056480176 | K091393 | 000 |
| 06430056480169 | K091393 | 000 |
| 06430056480152 | K091393 | 000 |
| 06430056480145 | K091393 | 000 |
| 06430056480008 | K091393 | 000 |