The following data is part of a premarket notification filed by Neuroelectrics Barcelona S.l.u. with the FDA for Enobio Wireless Eeg.
| Device ID | K162681 |
| 510k Number | K162681 |
| Device Name: | Enobio Wireless EEG |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Neuroelectrics Barcelona S.L.U. Avenida Tibidabo 47 Bis Barcelona, ES 08035 |
| Contact | Anna Maiques |
| Correspondent | Deirdre Barrow Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2017-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18436612820283 | K162681 | 000 |
| 18436612823048 | K162681 | 000 |
| 18436612823055 | K162681 | 000 |
| 18436612823062 | K162681 | 000 |
| 18436612823079 | K162681 | 000 |
| 08437017440390 | K162681 | 000 |
| 18437017440618 | K162681 | 000 |
| 18437017440625 | K162681 | 000 |
| 08437017440383 | K162681 | 000 |
| 18437017440656 | K162681 | 000 |
| 08437017440376 | K162681 | 000 |
| 18437017440670 | K162681 | 000 |
| 08437017440406 | K162681 | 000 |
| 18436612823000 | K162681 | 000 |
| 18436612823017 | K162681 | 000 |
| 18436612823024 | K162681 | 000 |
| 18436612820269 | K162681 | 000 |
| 18436612820276 | K162681 | 000 |
| 18436612823031 | K162681 | 000 |