The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Neuro Ii-se, Models: Or-dr-or, Or-mb.
| Device ID | K071099 |
| 510k Number | K071099 |
| Device Name: | NEURO II-SE, MODELS: OR-DR-OR, OR-MB |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Contact | Thomas M Tsakeris |
| Correspondent | Thomas M Tsakeris IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-19 |
| Decision Date | 2007-05-22 |
| Summary: | summary |