Neuro Omega System; NeuroSmart System— 510(k) K250601

Name: FDA 510(k) clearance K250601
Creator: U.S. Food and Drug Administration
Published: 2025-03-30

Substantially Equivalent

Alpha Omega Engineering , Ltd.

FDA 510(k) clearance K250601 for Neuro Omega System; NeuroSmart System, Substantially Equivalent on 2025-03-30. Applicant: Alpha Omega Engineering , Ltd.. Device class: 2.

Clearance details

Applicant: Alpha Omega Engineering , Ltd.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2025-02-28
Decision date: 2025-03-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Nof Hagalil (Nazareth Illit), IL

Download summary PDF View on FDA.gov ↗

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