Cleared Traditional

K173567 - Sera
(FDA 510(k) Clearance)

K173567 · Interacoustics A/S · Ear, Nose, Throat device

Feb 2018

Decision

86d

Days

Class 2

Risk

K173567 is an FDA 510(k) clearance for the Sera. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).

Submitted by Interacoustics A/S (Middelfart, DK). The FDA issued a Cleared decision on February 14, 2018, 86 days after receiving the submission on November 20, 2017.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number	K173567 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 20, 2017
Decision Date	February 14, 2018
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF