VisualEyes— 510(k) K200534

Substantially Equivalent

Interacoustics A/S

FDA 510(k) clearance K200534 for VisualEyes, Substantially Equivalent on 2020-08-12. 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: 2020-03-02
Decision date: 2020-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middelfart, DK

Download summary PDF View on FDA.gov ↗

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