The following data is part of a premarket notification filed by Cyberkinetics, Inc. with the FDA for Neuroport Neural Signal Processing System.
| Device ID | K060523 |
| 510k Number | K060523 |
| Device Name: | NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM |
| Classification | Reduced- Montage Standard Electroencephalograph |
| Applicant | CYBERKINETICS, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring CYBERKINETICS, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-27 |
| Decision Date | 2006-03-28 |
| Summary: | summary |