Cleared Traditional

CAREFUSION NICOLET EDX

K112052 · Carefusion 209, Inc. · Neurology
Mar 2012
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K112052 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 March 15, 2012, 241 days after receiving the submission on July 18, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K112052 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2011
Decision Date March 15, 2012
Days to Decision 241 days
Submission Type Traditional
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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