Cleared Special

CAREFUSION NICOLET EDX

K120979 · Carefusion 209, Inc. · Neurology
Apr 2012
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K120979 is an FDA 510(k) clearance for the CAREFUSION NICOLET EDX, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Carefusion 209, Inc. (Middleton, US). The FDA issued a Cleared decision on April 25, 2012, 23 days after receiving the submission on April 2, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K120979 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2012
Decision Date April 25, 2012
Days to Decision 23 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWF — Stimulator, Electrical, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1870

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