The following data is part of a premarket notification filed by Nordicneurolab with the FDA for Nordicbrainex.
| Device ID | K133910 |
| 510k Number | K133910 |
| Device Name: | NORDICBRAINEX |
| Classification | System, Image Processing, Radiological |
| Applicant | NORDICNEUROLAB MOLLENDALSVEIEN 65C Bergen, NO N-5009 |
| Contact | Chandana Gurung Bhandari |
| Correspondent | Chandana Gurung Bhandari NORDICNEUROLAB MOLLENDALSVEIEN 65C Bergen, NO N-5009 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-04-04 |
| Summary: | summary |