NEURONAUTE— 510(k) K170138

Substantially Equivalent

Bioserenity

FDA 510(k) clearance K170138 for NEURONAUTE, Substantially Equivalent on 2017-12-26. Applicant: Bioserenity. Device class: 2.

Clearance details

Applicant: Bioserenity
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2017-01-17
Decision date: 2017-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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K221959 — Q212023-08-31

More clearances from Bioserenity

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Data sourced from openFDA. This site is unofficial and independent of the FDA.