Cleared Traditional

LARYNGEAL SURFACE ELECTRODE

K093373 · Spes Medica Srl · Ear, Nose, Throat
Aug 2010
Decision
299d
Days
Class 2
Risk

About This 510(k) Submission

K093373 is an FDA 510(k) clearance for the LARYNGEAL SURFACE ELECTRODE, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Spes Medica Srl (Battipaglia, IT). The FDA issued a Cleared decision on August 24, 2010, 299 days after receiving the submission on October 29, 2009. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K093373 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2009
Decision Date August 24, 2010
Days to Decision 299 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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