K242326

Substantially Equivalent

Wave Electrode (AE02-60); Wave Electrode (AE02-50)

Applicant: Bionit Labs Srl
Product code: GXY
Advisory panel: Neurology
Date received: 2024-08-06
Decision date: 2025-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Soleto, IT

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