The following data is part of a premarket notification filed by Nordicneurolab with the FDA for Fmri Hardware System.
| Device ID | K080515 |
| 510k Number | K080515 |
| Device Name: | FMRI HARDWARE SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | NORDICNEUROLAB MOLLENDALSVEIEN 65C Bergen, NO N-5009 |
| Contact | Stian Scisly Sagevik |
| Correspondent | Stian Scisly Sagevik NORDICNEUROLAB MOLLENDALSVEIEN 65C Bergen, NO N-5009 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-25 |
| Decision Date | 2008-05-16 |
| Summary: | summary |