MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE— 510(k) K071186

Name: FDA 510(k) clearance K071186
Creator: U.S. Food and Drug Administration
Published: 2007-07-30

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K071186 for MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE, Substantially Equivalent on 2007-07-30. Applicant: Ambu A/S. Device class: 2.

Clearance details

Applicant: Ambu A/S
Product code: Code IKT
Device class: Class 2
Regulation: 21 CFR 890.1385
Advisory panel: Physical Medicine
Date received: 2007-04-30
Decision date: 2007-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glen Burnie, MD, US

Download summary PDF View on FDA.gov ↗

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