Cleared Special

K203807 - Ponto Bone Anchored Hearing System, MONO Surgery Kit
(FDA 510(k) Clearance)

K203807 · Oticon Medical AB · Ear, Nose, Throat

Mar 2021

Decision

65d

Days

Class 2

Risk

K203807 is an FDA 510(k) clearance for the Ponto Bone Anchored Hearing System, MONO Surgery Kit, a Hearing Aid, Bone Conduction, Implanted (Class II — Special Controls, product code MAH), submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on March 3, 2021, 65 days after receiving the submission on December 28, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3302.

Submission Details

510(k) Number	K203807 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 2020
Decision Date	March 03, 2021
Days to Decision	65 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF