HBIDB - HUMAN BRIAN INDEX SOFTWARE— 510(k) K112077

Name: FDA 510(k) clearance K112077
Creator: U.S. Food and Drug Administration
Published: 2012-03-09

Substantially Equivalent

Corscience GmbH & Co. KG

FDA 510(k) clearance K112077 for HBIDB - HUMAN BRIAN INDEX SOFTWARE, Substantially Equivalent on 2012-03-09. Applicant: Corscience GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Corscience GmbH & Co. KG
Product code: Code OLU
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2011-07-21
Decision date: 2012-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroeville, PA, US

Download summary PDF View on FDA.gov ↗

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