NEUROGUIDE ANALYSIS SYSTEM— 510(k) K041263

Name: FDA 510(k) clearance K041263
Creator: U.S. Food and Drug Administration
Published: 2004-08-03

Substantially Equivalent

Applied Neuroscience, Inc.

FDA 510(k) clearance K041263 for NEUROGUIDE ANALYSIS SYSTEM, Substantially Equivalent on 2004-08-03. Applicant: Applied Neuroscience, Inc.. Device class: 2.

Clearance details

Applicant: Applied Neuroscience, Inc.
Product code: Code OLU
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2004-05-11
Decision date: 2004-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, US

Download summary PDF View on FDA.gov ↗

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