Cleared Traditional

MR Conditional Sticky Pad Electrode

K203079 · Rhythmlink International, LLC · Neurology
Feb 2021
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K203079 is an FDA 510(k) clearance for the MR Conditional Sticky Pad 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 February 9, 2021, 119 days after receiving the submission on October 13, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K203079 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2020
Decision Date February 09, 2021
Days to Decision 119 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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