NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY— 510(k) K993622

Name: FDA 510(k) clearance K993622
Creator: U.S. Food and Drug Administration
Published: 2000-01-24

Substantially Equivalent

Alpha Omega , Ltd.

FDA 510(k) clearance K993622 for NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY, Substantially Equivalent on 2000-01-24. Applicant: Alpha Omega , Ltd.. Device class: 2.

Clearance details

Applicant: Alpha Omega , Ltd.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 1999-10-26
Decision date: 2000-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Ananna 43373, 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.