The following data is part of a premarket notification filed by Nordicneurolab with the FDA for Modification To Fmri Hardware System.
| Device ID | K092253 |
| 510k Number | K092253 |
| Device Name: | MODIFICATION TO FMRI HARDWARE SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| 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 | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-28 |
| Decision Date | 2009-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07090042059022 | K092253 | 000 |
| 07090042054058 | K092253 | 000 |
| 07090042051057 | K092253 | 000 |
| 07090042051033 | K092253 | 000 |
| 07090042051040 | K092253 | 000 |
| 07090042052016 | K092253 | 000 |
| 07090042052023 | K092253 | 000 |
| 07090042053013 | K092253 | 000 |
| 07090042053020 | K092253 | 000 |
| 07090042053044 | K092253 | 000 |
| 07090042054010 | K092253 | 000 |
| 07090042054027 | K092253 | 000 |
| 07090042054034 | K092253 | 000 |
| 07090042055017 | K092253 | 000 |
| 07090042055024 | K092253 | 000 |
| 07090042054041 | K092253 | 000 |