Cleared Traditional

K200529 - Orion (FDA 510(k) Clearance)

K200529 · Interacoustics A/S · Ear, Nose, Throat device
Aug 2020
Decision
163d
Days
-
Risk

K200529 is an FDA 510(k) clearance for the Orion. This device is classified as a Apparatus, Vestibular Analysis.

Submitted by Interacoustics A/S (Middelfart, DK). The FDA issued a Cleared decision on August 12, 2020, 163 days after receiving the submission on March 2, 2020.

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

Submission Details

510(k) Number K200529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date August 12, 2020
Days to Decision 163 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LXV - Apparatus, Vestibular Analysis
Device Class -