The following data is part of a premarket notification filed by Incereb Ltd with the FDA for Neon Eeg.
| Device ID | K151576 |
| 510k Number | K151576 |
| Device Name: | Neon EEG |
| Classification | Electrode, Cutaneous |
| Applicant | Incereb Ltd CENTRE OF APPLIED SCIENCE FOR HEALTH, INSTITUTE OF TECHNOLOGY TALLAGHT Dublin, IE Dublin24 |
| Contact | Paul Phillips |
| Correspondent | Paul Phillips INCEREB LTD CENTRE OF APPLIED SCIENCE FOR HEALTH, INSTITUTE OF TECHNOLOGY TALLAGHT Dublin, IE Dublin24 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-11 |
| Decision Date | 2015-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391530950053 | K151576 | 000 |
| 05391530950022 | K151576 | 000 |
| 05391530950084 | K151576 | 000 |
| 05391530950121 | K151576 | 000 |
| 05391530950091 | K151576 | 000 |