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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Synapsys SA. It received FDA 510(k) clearance on 2017-03-23 under 510(k) 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. The listed applicant is Synapsys SA. The 510(k) number is K163558.

When did Synapsys Ulmer Video Nystagmograph receive FDA 510(k) clearance?

Synapsys Ulmer Video Nystagmograph received FDA 510(k) clearance on 2017-03-23, under 510(k) number K163558.

Who is the listed applicant for Synapsys Ulmer Video Nystagmograph?

The FDA 510(k) record lists Synapsys SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synapsys Ulmer Video Nystagmograph?

The FDA product code for Synapsys Ulmer Video Nystagmograph is GWN.

Related Devices (Code: GWN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.K243709NeuroEars-Anna™Neuroears, Inc.K242198ICS Dizcovery (1091)Natus Medical Denmark ApsK242726Synapsys VHITInventis S.R.L.K223047NeuroSwift ProNeurobit Technologies Co., Ltd.K203082Insight Infrared Video GogglesVestibular First

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.

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