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FDA 510(k)

Insight Infrared Video Goggles

K-Number: K203082 · 2020-11-12

ApplicantVestibular First
Decision Date2020-11-12
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Insight Infrared Video Goggles is the device name listed in this FDA 510(k) record. The listed applicant is Vestibular First. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K203082. 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 Insight Infrared Video Goggles?

Insight Infrared Video Goggles is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Vestibular First. The 510(k) number is K203082.

When did Insight Infrared Video Goggles receive FDA 510(k) clearance?

Insight Infrared Video Goggles received FDA 510(k) clearance on 2020-11-12, under 510(k) number K203082.

Who is the listed applicant for Insight Infrared Video Goggles?

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

What is the FDA product code for Insight Infrared Video Goggles?

The FDA product code for Insight Infrared Video Goggles 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.K200534VisualEyesInteracoustics A/S

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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