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