NICOLETONE SYSTEM V32 AMPLIFIER— 510(k) K061908

Name: FDA 510(k) clearance K061908
Creator: U.S. Food and Drug Administration
Published: 2006-11-06

Substantially Equivalent

Viasys Neuro Care

FDA 510(k) clearance K061908 for NICOLETONE SYSTEM V32 AMPLIFIER, Substantially Equivalent on 2006-11-06. Applicant: Viasys Neuro Care. Device class: 2.

Clearance details

Applicant: Viasys Neuro Care
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2006-07-05
Decision date: 2006-11-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Stoughton, WI, US

Download summary PDF View on FDA.gov ↗

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