Orion

Apparatus, Vestibular Analysis

Lnteracoustics A/S

The following data is part of a premarket notification filed by Lnteracoustics A/s with the FDA for Orion.

Pre-market Notification Details

• Device ID: K200529
• 510k Number: K200529
• Device Name: Orion
• Classification: Apparatus, Vestibular Analysis
• Applicant: lnteracoustics A/S Audiometer Alle 1 Middelfart, DK Dk-5500
• Contact: Erik Nielsen
• Correspondent: Erik Nielsen; lnteracoustics A/S Audiometer Alle 1 Middelfart, DK Dk-5500
• Product Code: LXV
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-02
• Decision Date: 2020-08-12