VisualEyes

Nystagmograph

Interacoustics A/S

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

Pre-market Notification Details

• Device ID: K163149
• 510k Number: K163149
• Device Name: VisualEyes
• Classification: Nystagmograph
• Applicant: Interacoustics A/S Audiometer Alle 1 Middelfart, DK 5500
• Contact: Erik Nielsen
• Correspondent: Erik Nielsen; Interacoustics A/S Audiometer Alle 1 Middelfart, DK 5500
• Product Code: GWN
• CFR Regulation Number: 882.1460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-09
• Decision Date: 2017-04-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05711117195989	K163149	000