Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- GXWEchoencephalograph2Product Code
- GXXBlock, Test, Ultrasonic Scanner Calibration1Product Code
- GXYElectrode, Cutaneous2Product Code
- GXZElectrode, Needle2Product Code
- GYATester, Electrode/Lead, Electroencephalograph1Product Code
- GXSMonitor, Alpha2Product Code
- GWEStimulator, Photic, Evoked Response2Product Code
- GWFStimulator, Electrical, Evoked Response2Product Code
- GWGEndoscope, Neurological2Product Code
- GWIDiscriminator, Two-Point1Product Code
- GWJStimulator, Auditory, Evoked Response2Product Code
- GWKConditioner, Signal, Physiological2Product Code
- GWLAmplifier, Physiological Signal2Product Code
- GWMDevice, Monitoring, Intracranial Pressure2Product Code
- GWNNystagmograph2Product Code
- K243709NeuroEars-Anna™2Cleared 510(K)
- K242198ICS Dizcovery (1091)2Cleared 510(K)
- K242726Synapsys VHIT2Cleared 510(K)
- K223047NeuroSwift Pro2Cleared 510(K)
- K203082Insight Infrared Video Goggles2Cleared 510(K)
- K200534VisualEyes2Cleared 510(K)
- K192186I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph2Cleared 510(K)
- K181771RightEye Vision System2Cleared 510(K)
- K182214DizzyDoctor System 1.0.02Cleared 510(K)
- K181025I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System2Cleared 510(K)
- K171884I-Portal Portable Assessment System - Nystagmograph (I-PAS)2Cleared 510(K)
- K163270ISEN-Goggles with Data Viewer2Cleared 510(K)
- K163149VisualEyes2Cleared 510(K)
- K163558Synapsys Ulmer Video Nystagmograph2Cleared 510(K)
- K152727ISEN-Goggles2Cleared 510(K)
- K152915EYE-SYNC2Cleared 510(K)
- K152112VisualEyes2Cleared 510(K)
- K151504ICS Impulse2Cleared 510(K)
- K143607I-Portal NOTC, VNG and VOG2Cleared 510(K)
- K131681EYESEECAM VHIT2Cleared 510(K)
- K130201NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM2Cleared 510(K)
- K122550ICS IMPULSE2Cleared 510(K)
- K083603I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL2Cleared 510(K)
- K072254VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM2Cleared 510(K)
- K070670EYETRACKER/IDEAS2Cleared 510(K)
- K070729BALANCEBACK MOBILE INTUITIVE VNG SYSTEM2Cleared 510(K)
- K062015CHRONOS VISION EYE TRACKING DEVICE (C-ETD)2Cleared 510(K)
- K061791FOCUS VNG/ENG TYPE 10682Cleared 510(K)
- K050098DDAT OMT2Cleared 510(K)
- K042529BALANCEBACK VNG SYSTEM2Cleared 510(K)
- K013060ICS MEDICAL MODEL VG-30 VIDEO GOGGLES2Cleared 510(K)
- K010059ENGPLUS2Cleared 510(K)
- K003644EYETECT TREMOR MONITOR UNIT (TMU)2Cleared 510(K)
- K992473EXPRESSEYE2Cleared 510(K)
- K991642EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX2Cleared 510(K)
- K991497ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM2Cleared 510(K)
- K982103ULMER (VNG) VIDEO NYSTAGMOGRAPH2Cleared 510(K)
- K972631ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER2Cleared 510(K)
- K9722432D VOG - VIDEO-OCULOGRAPHY2Cleared 510(K)
- K964646VIDEO EYE TRAKKER2Cleared 510(K)
- K964325VISUALEYES: VIDEO EYE MONITOR2Cleared 510(K)
- K941928VARIOUS ELECTRODES2Cleared 510(K)
- K926312INFRARED EYE MOVEMENT MONITOR2Cleared 510(K)
- K925111HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM2Cleared 510(K)
- K904385JANUS ATAC ENG ANALYSIS SYSTEM2Cleared 510(K)
- K884294NICOLET NYSTAR PLUS SYSTEM2Cleared 510(K)
- K871466VESTIBULAR AUTOROTATION TEST2Cleared 510(K)
- K863424COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE2Cleared 510(K)
- K860457ELECTROCARDIOGRAPH CONTINUOUS MONITOR2Cleared 510(K)
- K851190NYSTAGMOGRAPH EOG/ENG ANALYSES2Cleared 510(K)
- K850180ELECTRONYSTAGMOGRAPH (ENG RECORDER)2Cleared 510(K)
- K842886TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL2Cleared 510(K)
- K843004SERVO MED NYSTAGMOGRAPH NG-12Cleared 510(K)
- K834148PHILLY BOLTS2Cleared 510(K)
- K822268NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH2Cleared 510(K)
- K823459PHILLY BOLT ADULT PROCEDURE KIT2Cleared 510(K)
- K822266NAGASHIMA KN-52 SACCADE & PURSUIT STIM2Cleared 510(K)
- K820151PHILLY INFANT BOLT2Cleared 510(K)
- K812180LIFE-TECH #5102 VISULAB2Cleared 510(K)
- GWQFull-Montage Standard Electroencephalograph2Product Code
- GWRGenerator, Electroencephalograph Test Signal1Product Code
- GWSAnalyzer, Spectrum, Electroencephalogram Signal1Product Code
- GWWAtaxiagraph1Product Code
- GWXFork, Tuning1Product Code
- GWYPinwheel1Product Code
- GWZPercussor1Product Code
- GXBEsthesiometer1Product Code
- GYBMedia, Electroconductive2Product Code
- GYCElectrode, Cortical2Product Code
- GYDTransducer, Tremor2Product Code
- GYEEncephalogram Telemetry System2Product Code
- GZKElectrode, Nasopharyngeal2Product Code
- GZLElectrode, Depth2Product Code
- GZMAnalyzer, Rigidity2Product Code
- GZNRheoencephalograph3Product Code
- GZODevice, Galvanic Skin Response Measurement2Product Code
- GZPStimulator, Mechanical, Evoked Response2Product Code
- HCJDevice, Skin Potential Measurement2Product Code
- HCSDevice, Temperature Measurement, Direct Contact, Powered2Product Code
- JXEDevice, Nerve Conduction Velocity Measurement2Product Code
- JXFPlethysmograph, Ocular3Product Code
- LLNDevice, Vibration Threshold Measurement1Product Code
- LQWTest, Temperature Discrimination1Product Code
- NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid2Product Code
- NTUEvoked Potential Stimulator, Thermal2Product Code
- OLTNon-Normalizing Quantitative Electroencephalograph Software2Product Code
- OLUNormalizing Quantitative Electroencephalograph Software2Product Code
- OLVStandard Polysomnograph With Electroencephalograph2Product Code
- OLWIndex-Generating Electroencephalograph Software2Product Code
- OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph2Product Code
- OLYMagnetoencephalograph2Product Code
- OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph2Product Code
- OMAAmplitude-Integrated Electroencephalograph2Product Code
- OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph2Product Code
- OMCReduced- Montage Standard Electroencephalograph2Product Code
- ORTBurst Suppression Detection Software For Electroencephalograph2Product Code
- PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid2Product Code
- PKQComputerized Cognitive Assessment Aid2Product Code
- PNAEvoked Photon Image Capture Device1Product Code
- POMComputerized Cognitive Assessment Aid For Concussion2Product Code
- POPCranial Motion Measurement Device2Product Code
- POSPhysiological Signal Based Seizure Monitoring System2Product Code
- PSPIntracranial Pressure & Temperature Monitoring Kit2Product Code
- PTBAtaxiagraph With Interpretive Software1Product Code
- PTYComputerized Cognitive Assessment Aid, Exempt2Product Code
- PVPNeurological Test Kit1Product Code
- QEABrain Injury Adjunctive Interpretive Oculomotor Assessment Aid2Product Code
- QPFPediatric Autism Spectrum Disorder Diagnosis Aid2Product Code
- OPTInfrared Hematoma Detector2Product Code
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ISEN-Goggles
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K152727
- 510(k) Type
- Traditional
- Applicant
- Isen Tech & Trading Company, Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/26/2016
- Days to Decision
- 217 days
- Submission Type
- Summary