Cleared Traditional

BNA ANALYSIS SYSTEM

K121119 · Eiminda , Ltd. · Neurology

Jul 2014

Decision

834d

Days

Class 2

Risk

About This 510(k) Submission

K121119 is an FDA 510(k) clearance for the BNA ANALYSIS SYSTEM, a Normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLU), submitted by Eiminda , Ltd. (Herzliya, IL). The FDA issued a Cleared decision on July 25, 2014, 834 days after receiving the submission on April 12, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K121119 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2012
Decision Date	July 25, 2014
Days to Decision	834 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLU — Normalizing Quantitative Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A Qualified User.