Cleared Traditional

NICOLET WIRELESS EEG

K103140 · Carefusion 209, Inc. · Neurology
Apr 2011
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K103140 is an FDA 510(k) clearance for the NICOLET WIRELESS EEG, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Carefusion 209, Inc. (Middleton, US). The FDA issued a Cleared decision on April 8, 2011, 165 days after receiving the submission on October 25, 2010. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K103140 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2010
Decision Date April 08, 2011
Days to Decision 165 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835