NEURONAUTE
Full-montage Standard Electroencephalograph
BIOSERENITY
The following data is part of a premarket notification filed by Bioserenity with the FDA for Neuronaute.
Pre-market Notification Details
| Device ID | K170138 |
| 510k Number | K170138 |
| Device Name: | NEURONAUTE |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | BIOSERENITY 47 Boulevard De L'Hopital Paris, FR 75013 |
| Contact | Quang Tran |
| Correspondent | Esin Yesilalan Voisin Consulting Inc. Life Sciences 222 Third Street Suite 3121 Cambridge, MA 02142 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-17 |
| Decision Date | 2017-12-26 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03615220001217 | K170138 | 000 |
| 03615220001200 | K170138 | 000 |
| 03615220001194 | K170138 | 000 |
| 03615220001187 | K170138 | 000 |
| 03615220001170 | K170138 | 000 |
| 03615220001163 | K170138 | 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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