Neuro Omega System— 510(k) K171581

Name: FDA 510(k) clearance K171581
Creator: U.S. Food and Drug Administration
Published: 2017-12-22

Substantially Equivalent

Alpha Omega Engineering , Ltd.

FDA 510(k) clearance K171581 for Neuro Omega System, Substantially Equivalent on 2017-12-22. 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: 2017-05-31
Decision date: 2017-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nazareth, IL

Download summary PDF View on FDA.gov ↗

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Recalls naming K171581

K-number listed on FDA's recall record

Z-1216-2019 — Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.Class I·Terminated·Alpha Omega Engineering·20180904

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171581.

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