The following data is part of a premarket notification filed by Nordicneurolab As with the FDA for Fmri Hardware System.
| Device ID | K191032 |
| 510k Number | K191032 |
| Device Name: | FMRI Hardware System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | NordicNeurolab AS Mollendalsveien1 Bergen, NO 5009 |
| Contact | Chandana Gurung Bhandari |
| Correspondent | Chandana Gurung Bhandari NordicNeurolab AS Mollendalsveien1 Bergen, NO 5009 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-18 |
| Decision Date | 2019-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07090042052092 | K191032 | 000 |
| 07090042052085 | K191032 | 000 |
| 07090042052061 | K191032 | 000 |
| 07090042052108 | K191032 | 000 |