BNA Platform— 510(k) K202588

Substantially Equivalent

Elminda, Ltd.

FDA 510(k) clearance K202588 for BNA Platform, Substantially Equivalent on 2020-12-07. Applicant: Elminda, Ltd.. Device class: 2.

Clearance details

Applicant: Elminda, Ltd.
Product code: Code OLU
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2020-09-08
Decision date: 2020-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herzliya, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLU

K253015 — Cognitive Function Neuroimaging (cfNI) Software (1.0.0)2026-06-12
K240420 — NeuroField Analysis Suite2024-09-20
K222838 — iSyncBrain©-C2023-03-16
K212684 — BrainView QEEG Software2023-01-28
K191432 — cortiQ PRO2020-01-24

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