Cleared Traditional

K192652 - TRV (FDA 510(k) Clearance)

K192652 · Interacoustics A/S · Ear, Nose, Throat device
May 2020
Decision
246d
Days
-
Risk

K192652 is an FDA 510(k) clearance for the TRV. This device is classified as a Apparatus, Vestibular Analysis.

Submitted by Interacoustics A/S (Middelfart, DK). The FDA issued a Cleared decision on May 27, 2020, 246 days after receiving the submission on September 24, 2019.

This device falls under the Ear, Nose, Throat FDA review panel.

Submission Details

510(k) Number K192652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2019
Decision Date May 27, 2020
Days to Decision 246 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LXV - Apparatus, Vestibular Analysis
Device Class -