Cleared Traditional

RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT

K072736 · Rhythmlink International, LLC · Ear, Nose, Throat
Jan 2008
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K072736 is an FDA 510(k) clearance for the RHYTHMLINK INTERNATIONAL 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 January 22, 2008, 117 days after receiving the submission on September 27, 2007. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K072736 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2007
Decision Date January 22, 2008
Days to Decision 117 days
Submission Type Traditional
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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