Neuronaute
Full-montage Standard Electroencephalograph
Bioserenity SAS
The following data is part of a premarket notification filed by Bioserenity Sas with the FDA for Neuronaute.
Pre-market Notification Details
| Device ID | K202334 |
| 510k Number | K202334 |
| Device Name: | Neuronaute |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Bioserenity SAS ICM-iPEPS, 47 Boulevard De L'Hopital Paris, FR 75013 |
| Contact | Julien Dupont |
| Correspondent | Julien Dupont Bioserenity SAS ICM-iPEPS, 47 Boulevard De L'Hopital Paris, FR 75013 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-17 |
| Decision Date | 2020-12-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03615220001774 | K202334 | 000 |
| 03615220001521 | K202334 | 000 |
| 03615220003624 | K202334 | 000 |
| 03615220001798 | K202334 | 000 |
| 03615220001781 | K202334 | 000 |
| 03615220001729 | K202334 | 000 |
| 03615220004171 | K202334 | 000 |
Trademark Results [Neuronaute]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEURONAUTE 86852894 5268785 Live/Registered |
BioSerenity SAS 2015-12-17 |
 NEURONAUTE 79247794 not registered Live/Pending |
Bioserenity 2018-10-05 |
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