The following data is part of a premarket notification filed by Cyberkinetics, Inc. with the FDA for Neuroport Neural Signal Processor (nsp) System.
| Device ID | K042626 |
| 510k Number | K042626 |
| Device Name: | NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | CYBERKINETICS, INC. 100 FOXBORO BLVD. SUITE 240 Foxboro, MA 02035 |
| Contact | Burke T Barrett |
| Correspondent | Burke T Barrett CYBERKINETICS, INC. 100 FOXBORO BLVD. SUITE 240 Foxboro, MA 02035 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2005-03-28 |
| Summary: | summary |