Cleared Special

RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT

K112435 · Rhythmlink International, LLC · Ear, Nose, Throat
Sep 2011
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K112435 is an FDA 510(k) clearance for the RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on September 22, 2011, 29 days after receiving the submission on August 24, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K112435 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2011
Decision Date September 22, 2011
Days to Decision 29 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

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