Neuronaute with IceCap 2 & IceCap 2 Small— 510(k) K223644

Name: FDA 510(k) clearance K223644
Creator: U.S. Food and Drug Administration
Published: 2023-01-12

Substantially Equivalent

Bioserenity

FDA 510(k) clearance K223644 for Neuronaute with IceCap 2 & IceCap 2 Small, Substantially Equivalent on 2023-01-12. 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: 2022-12-06
Decision date: 2023-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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