Cleared Traditional

TRV

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

About This 510(k) Submission

K192652 is an FDA 510(k) clearance for the TRV, 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 review panel.

Submission Details

510(k) Number K192652 FDA.gov
FDA Decision Cleared 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 —