Cleared Traditional

Orion

K200529 · Interacoustics A/S · Ear, Nose, Throat

Aug 2020

Decision

163d

Days

—

Risk

About This 510(k) Submission

K200529 is an FDA 510(k) clearance for the Orion, 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 review panel.

Submission Details

510(k) Number	K200529 FDA.gov
FDA Decision	Cleared 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