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510(k) K223047

Device
NeuroSwift Pro
Applicant
Neurobit Technologies Co., Ltd.
510(k) number
K223047
Product code
GWN
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-29
Date received
2022-09-29
Regulation
882.1460
Classification name
Nystagmograph
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Chun-Chen Yang
Address
2f, # 320 Sec 4, Zhongxiao E. Rd. Taipei TW 10694 10694

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GWN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243709NeuroEars-Anna™Neuroears, Inc.2025-08-25
K242198ICS Dizcovery (1091)Natus Medical Denmark Aps2025-02-14
K242726Synapsys VHITInventis S.R.L.2025-01-03
K203082Insight Infrared Video GogglesVestibular First2020-11-12
K200534VisualEyesInteracoustics A/S2020-08-12
K192186I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - NysragmographNeurolign USA, LLC2019-11-29
K181771RightEye Vision SystemRighteye, LLC2018-09-28
K182214DizzyDoctor System 1.0.0Dizzydoctor Systems, LLC2018-09-14
K181025I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking SystemNeuro Kinetics, Inc.2018-07-24
K171884I-Portal Portable Assessment System - Nystagmograph (I-PAS)Neuro Kinetics, Inc.2017-11-22
K163270ISEN-Goggles with Data ViewerIsent Tech & Trading Company, Ltd.2017-09-25
K163149VisualEyesInteracoustics A/S2017-04-26
K163558Synapsys Ulmer Video NystagmographSynapsys SA2017-03-23
K152727ISEN-GogglesIsen Tech & Trading Company, Ltd.2016-04-26
K152915EYE-SYNCSyncthink, Inc.2016-01-29