Synapsys Ulmer Video Nystagmograph— 510(k) K163558

Substantially Equivalent

Synapsys SA

FDA 510(k) clearance K163558 for Synapsys Ulmer Video Nystagmograph, Substantially Equivalent on 2017-03-23. Applicant: Synapsys SA. Device class: 2.

Clearance details

Applicant: Synapsys SA
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2016-12-19
Decision date: 2017-03-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Marseille, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.