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

Substantially Equivalent

Bioserenity

FDA 510(k) clearance K223644 for Neuronaute with IceCap 2 & IceCap 2 Small, Substantially Equivalent on 2023-01-12. Applicant: Bioserenity.

Clearance details

Applicant: Bioserenity
Product code: Code GWQ
Advisory panel: Neurology
Date received: 2022-12-06
Decision date: 2023-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Paris, FR

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