BE PLUS LTM AMPLIFIER GWI AMPLIFIER— 510(k) K121996

Name: FDA 510(k) clearance K121996
Creator: U.S. Food and Drug Administration
Published: 2012-08-03

Substantially Equivalent

Eb Neuro S.P.A.

FDA 510(k) clearance K121996 for BE PLUS LTM AMPLIFIER GWI AMPLIFIER, Substantially Equivalent on 2012-08-03. Applicant: Eb Neuro S.P.A.. Device class: 2.

Clearance details

Applicant: Eb Neuro S.P.A.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2012-07-09
Decision date: 2012-08-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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