Cleared Traditional

K161671 - Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
(FDA 510(k) Clearance)

K161671 · Oticon Medical AB · Ear, Nose, Throat

Sep 2016

Decision

105d

Days

Class 2

Risk

K161671 is an FDA 510(k) clearance for the Ponto 3, Ponto 3 Power and Ponto 3 SuperPower, a Hearing Aid, Bone Conduction (Class II — Special Controls, product code LXB), submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on September 29, 2016, 105 days after receiving the submission on June 16, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3302.

Submission Details

510(k) Number	K161671 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2016
Decision Date	September 29, 2016
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF