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 IDK170138
510k NumberK170138
Device Name:NEURONAUTE
ClassificationFull-montage Standard Electroencephalograph
Applicant BIOSERENITY 47 Boulevard De L'Hopital Paris,  FR 75013
ContactQuang Tran
CorrespondentEsin Yesilalan
Voisin Consulting Inc. Life Sciences 222 Third Street Suite 3121 Cambridge,  MA  02142
Product CodeGWQ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-17
Decision Date2017-12-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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
NEURONAUTE
86852894 5268785 Live/Registered
BioSerenity SAS
2015-12-17
NEURONAUTE
NEURONAUTE
79247794 not registered Live/Pending
Bioserenity
2018-10-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.