Cleared Traditional

PROVOX FREEHANDS FLEXIVOICE

K141380 · Atos Medical AB · Ear, Nose, Throat
Sep 2014
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K141380 is an FDA 510(k) clearance for the PROVOX FREEHANDS FLEXIVOICE, a Prosthesis, Laryngeal (taub) (Class II — Special Controls, product code EWL), submitted by Atos Medical AB (Horby, SE). The FDA issued a Cleared decision on September 26, 2014, 122 days after receiving the submission on May 27, 2014. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3730.

Submission Details

510(k) Number K141380 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2014
Decision Date September 26, 2014
Days to Decision 122 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EWL — Prosthesis, Laryngeal (taub)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3730

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