Nelli (Version 7.11)— 510(k) K251506

Substantially Equivalent

Neuro Event Labs OY

FDA 510(k) clearance K251506 for Nelli (Version 7.11), Substantially Equivalent on 2025-11-21. Applicant: Neuro Event Labs OY. Device class: 2.

Clearance details

Applicant: Neuro Event Labs OY
Product code: Code POS
Device class: Class 2
Regulation: 21 CFR 882.1580
Advisory panel: Neurology
Date received: 2025-05-16
Decision date: 2025-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

Download summary PDF View on FDA.gov ↗

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