LORENZ BIOTECH APTIVA, VERSION 2.13— 510(k) K061828

Name: FDA 510(k) clearance K061828
Creator: U.S. Food and Drug Administration
Published: 2007-08-24

Substantially Equivalent

Lorenz Biotech S.P.A.

FDA 510(k) clearance K061828 for LORENZ BIOTECH APTIVA, VERSION 2.13, Substantially Equivalent on 2007-08-24. Applicant: Lorenz Biotech S.P.A.. Device class: 2.

Clearance details

Applicant: Lorenz Biotech S.P.A.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2006-06-28
Decision date: 2007-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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