Cleared Traditional

RHYTHMLINK DISC ELECTRODES

K061148 · Rhythmlink International, LLC · Neurology
May 2006
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K061148 is an FDA 510(k) clearance for the RHYTHMLINK DISC ELECTRODES, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on May 10, 2006, 15 days after receiving the submission on April 25, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K061148 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2006
Decision Date May 10, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1320

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