The following data is part of a premarket notification filed by Cyberkinetics Neurotechnology Systems, Inc. with the FDA for Neuroport Electrode.
| Device ID | K070272 |
| 510k Number | K070272 |
| Device Name: | NEUROPORT ELECTRODE |
| Classification | Electrode, Depth |
| Applicant | CYBERKINETICS NEUROTECHNOLOGY SYSTEMS, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring CYBERKINETICS NEUROTECHNOLOGY SYSTEMS, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-29 |
| Decision Date | 2007-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814901020094 | K070272 | 000 |
| 00814901020087 | K070272 | 000 |
| 00814901020063 | K070272 | 000 |
| 00814901020018 | K070272 | 000 |