Synapsys Ulmer Video Nystagmograph
K-Number: K163558 · 2017-03-23
ApplicantSynapsys SA
Decision Date2017-03-23
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Synapsys Ulmer Video Nystagmograph is a medical device manufactured by Synapsys SA. It received FDA 510(k) clearance on 2017-03-23 under approval number K163558. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Synapsys Ulmer Video Nystagmograph?
Synapsys Ulmer Video Nystagmograph is a medical device that received FDA 510(k) clearance on 2017-03-23. It is manufactured by Synapsys SA. The 510(k) number is K163558.
When was Synapsys Ulmer Video Nystagmograph approved by the FDA?
Synapsys Ulmer Video Nystagmograph received FDA 510(k) clearance on 2017-03-23, under approval number K163558.
What company makes Synapsys Ulmer Video Nystagmograph?
Synapsys Ulmer Video Nystagmograph is manufactured by Synapsys SA.
What is the FDA product code for Synapsys Ulmer Video Nystagmograph?
The FDA product code for Synapsys Ulmer Video Nystagmograph is GWN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.