Cleared Traditional

K103594 - PONTO PRO POWER (FDA 510(k) Clearance)

K103594 · Oticon Medical AB · Ear, Nose, Throat device
Jun 2011
Decision
189d
Days
Class 2
Risk

K103594 is an FDA 510(k) clearance for the PONTO PRO POWER. This device is classified as a Hearing Aid, Bone Conduction (Class II - Special Controls, product code LXB).

Submitted by Oticon Medical AB (Gothenburg, Askim, SE). The FDA issued a Cleared decision on June 15, 2011, 189 days after receiving the submission on December 8, 2010.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.

Submission Details

510(k) Number K103594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2010
Decision Date June 15, 2011
Days to Decision 189 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LXB - Hearing Aid, Bone Conduction
Device Class Class II - Special Controls
CFR Regulation 21 CFR 874.3302