K243788

Substantially Equivalent

IceCap product line

Applicant: Bioserenity Medical Devices Group
Product code: GXY
Advisory panel: Neurology
Date received: 2024-12-09
Decision date: 2025-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

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