Cleared Traditional

K191372 - Lyra (FDA 510(k) Clearance)

K191372 · Interacoustics A/S · Ear, Nose, Throat device
Jul 2019
Decision
54d
Days
Class 2
Risk

K191372 is an FDA 510(k) clearance for the Lyra. 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 July 15, 2019, 54 days after receiving the submission on May 22, 2019.

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

Submission Details

510(k) Number K191372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2019
Decision Date July 15, 2019
Days to Decision 54 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EWO - Audiometer
Device Class Class II - Special Controls
CFR Regulation 21 CFR 874.1050