NEURONAV SYSTEM AND NEURONAV DRIVE— 510(k) K071697

Name: FDA 510(k) clearance K071697
Creator: U.S. Food and Drug Administration
Published: 2007-12-03

Substantially Equivalent

Alpha Omega , Ltd.

FDA 510(k) clearance K071697 for NEURONAV SYSTEM AND NEURONAV DRIVE, Substantially Equivalent on 2007-12-03. 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: 2007-06-20
Decision date: 2007-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 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.