The following data is part of a premarket notification filed by Nordicneurolab with the FDA for Fmri Hardware System.
| Device ID | K073099 |
| 510k Number | K073099 |
| Device Name: | FMRI HARDWARE SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | NORDICNEUROLAB 6470 RIVERVIEW TERRACE NE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-02 |
| Decision Date | 2007-11-20 |
| Summary: | summary |