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: K152112
• 510k Number: K152112
• 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: 2015-07-29
• Decision Date: 2015-12-29
• Summary: summary