Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)— 510(k) K260453

Name: FDA 510(k) clearance K260453
Creator: U.S. Food and Drug Administration
Published: 2026-03-12

Substantially Equivalent

Bionit Labs Srl

FDA 510(k) clearance K260453 for Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60), Substantially Equivalent on 2026-03-12. Applicant: Bionit Labs Srl. Device class: 2.

Clearance details

Applicant: Bionit Labs Srl
Product code: Code GXY
Device class: Class 2
Regulation: 21 CFR 882.1320
Advisory panel: Neurology
Date received: 2026-02-11
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Soleto, IT

Download summary PDF View on FDA.gov ↗

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