The following data is part of a premarket notification filed by Nordicneurolab As with the FDA for Nordicbrainex.
| Device ID | K163324 |
| 510k Number | K163324 |
| Device Name: | NordicBrainEx |
| Classification | System, Image Processing, Radiological |
| Applicant | NordicNeurolab AS MOLLENDALSVEIEN 65C Bergen, NO N-5009 |
| Contact | Chandana Gurung Bhandari |
| Correspondent | Chandana Gurung Bhandari NordicNeurolab AS 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 | 2016-11-25 |
| Decision Date | 2017-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07090042059015 | K163324 | 000 |