The following data is part of a premarket notification filed by Imaging Biometrics, Llc with the FDA for Ib Neuro, Version 1.0.
| Device ID | K080762 |
| 510k Number | K080762 |
| Device Name: | IB NEURO, VERSION 1.0 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | IMAGING BIOMETRICS, LLC 1035 KATHERINE DR. Elm Grove, WI 53122 |
| Contact | Michael Schmainda |
| Correspondent | Michael Schmainda IMAGING BIOMETRICS, LLC 1035 KATHERINE DR. Elm Grove, WI 53122 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-18 |
| Decision Date | 2008-05-15 |
| Summary: | summary |