Cleared Traditional

PRESSON ELECTRODE

K121347 · Rhythmlink International, LLC · Neurology
Jul 2012
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K121347 is an FDA 510(k) clearance for the PRESSON ELECTRODE, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on July 12, 2012, 72 days after receiving the submission on May 1, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.

Submission Details

510(k) Number K121347 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2012
Decision Date July 12, 2012
Days to Decision 72 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GXZ — Electrode, Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1350

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