VisualEyes— 510(k) K163149

Substantially Equivalent

Interacoustics A/S

FDA 510(k) clearance K163149 for VisualEyes, Substantially Equivalent on 2017-04-26. Applicant: Interacoustics A/S. Device class: 2.

Clearance details

Applicant: Interacoustics A/S
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2016-11-09
Decision date: 2017-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middelfart, DK

Download summary PDF View on FDA.gov ↗

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