The following data is part of a premarket notification filed by Cyberkinetics, Inc. (cki) with the FDA for Neuroport Recording Microelectrode Array System.
| Device ID | K042384 |
| 510k Number | K042384 |
| Device Name: | NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM |
| Classification | Electrode, Depth |
| Applicant | CYBERKINETICS, INC. (CKI) 391 CHIPETA WAY SUITE G Salt Lake City, UT 84108 |
| Contact | Burke T Barrett |
| Correspondent | Burke T Barrett CYBERKINETICS, INC. (CKI) 391 CHIPETA WAY SUITE G Salt Lake City, UT 84108 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-01 |
| Decision Date | 2005-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814901020070 | K042384 | 000 |
| 00814901020056 | K042384 | 000 |
| 00814901020049 | K042384 | 000 |
| 00814901020001 | K042384 | 000 |
| 00814901021411 | K042384 | 000 |