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FDA 510(k)

ULMER (VNG) VIDEO NYSTAGMOGRAPH

K-Number: K982103 · 1998-09-11

ApplicantSynapsys, Inc.
Decision Date1998-09-11
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ULMER (VNG) VIDEO NYSTAGMOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Synapsys, Inc.. It received FDA 510(k) clearance on 1998-09-11 under 510(k) number K982103. 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 ULMER (VNG) VIDEO NYSTAGMOGRAPH?

ULMER (VNG) VIDEO NYSTAGMOGRAPH is a medical device that received FDA 510(k) clearance on 1998-09-11. The listed applicant is Synapsys, Inc.. The 510(k) number is K982103.

When did ULMER (VNG) VIDEO NYSTAGMOGRAPH receive FDA 510(k) clearance?

ULMER (VNG) VIDEO NYSTAGMOGRAPH received FDA 510(k) clearance on 1998-09-11, under 510(k) number K982103.

Who is the listed applicant for ULMER (VNG) VIDEO NYSTAGMOGRAPH?

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

What is the FDA product code for ULMER (VNG) VIDEO NYSTAGMOGRAPH?

The FDA product code for ULMER (VNG) VIDEO NYSTAGMOGRAPH is GWN.

Related Clinical Trials

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Other records listing Synapsys, Inc. as applicant

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.

K012415AURIS AEP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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