Cleared Traditional

CUTANEOUS ELECTRODE

K052188 · Rhythmlink International, LLC · Neurology
Aug 2005
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K052188 is an FDA 510(k) clearance for the CUTANEOUS ELECTRODE, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on August 23, 2005, 12 days after receiving the submission on August 11, 2005. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K052188 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2005
Decision Date August 23, 2005
Days to Decision 12 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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