Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Vestibular First. It received FDA 510(k) clearance on 2020-11-12 under approval 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. It is manufactured by Vestibular First. The 510(k) number is K203082.

When was Insight Infrared Video Goggles approved by the FDA?

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

What company makes Insight Infrared Video Goggles?

Insight Infrared Video Goggles is manufactured by Vestibular First.

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

The FDA product code for Insight Infrared Video Goggles is GWN.

Related Clinical Trials

NCT06921265 Targeted Transcranial Magnetic Stimulation to Improve Language and Speech in Patients With Primary Progressive Aphasia ENROLLING_BY_INVITATION

Related Devices (Code: GWN)

K152727ISEN-GogglesIsen Tech & Trading Company, Ltd. K152915EYE-SYNCSyncthink, Inc. K171884I-Portal Portable Assessment System - Nystagmograph (I-PAS)Neuro Kinetics, Inc. K163270ISEN-Goggles with Data ViewerIsent Tech & Trading Company, Ltd. K163149VisualEyesInteracoustics A/S K163558Synapsys Ulmer Video NystagmographSynapsys SA

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.

↑