Wave Electrode (AE02-60); Wave Electrode (AE02-50)— 510(k) K242326

Substantially Equivalent

Bionit Labs Srl

FDA 510(k) clearance K242326 for Wave Electrode (AE02-60); Wave Electrode (AE02-50), Substantially Equivalent on 2025-01-02. Applicant: Bionit Labs Srl.

Clearance details

Applicant: Bionit Labs Srl
Product code: 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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