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
- K221471E3 and Profile2Cleared 510(K)
- K212936Vision Monitor- MonCvONE2Cleared 510(K)
- K211974LED PHOTIC System2Cleared 510(K)
- K211643Vision Monitor - MonpackONE2Cleared 510(K)
- K200705Nurochek System2Cleared 510(K)
- K173936Natus Photic Stimulator2Cleared 510(K)
- K142567RETeval Visual Electrodiagnostic Device2Cleared 510(K)
- K113785ADHERENT VISUAL STIMULATOR GOGGLES2Cleared 510(K)
- K120104VISIONSEARCH 12Cleared 510(K)
- K101763DIOPSYS NOVA VEP VISION TESTING SYSTEM2Cleared 510(K)
- K101691LIFELINES PHOTIC STIMULATOR2Cleared 510(K)
- K081591NEUCODIA2Cleared 510(K)
- K043367GLAID OCULAR ELECTROPHYSIOLOGY DEVICE2Cleared 510(K)
- K043491ENFANTTM2Cleared 510(K)
- K023525RETISCAN, RETIPORT2Cleared 510(K)
- K022304ACCUMAP AUTOMATIC PERIMETER2Cleared 510(K)
- K011794XLTEK LED GOGGLES, MODEL LED-012Cleared 510(K)
- K001467DA VINCHI EMG/EP ISA1004EP2Cleared 510(K)
- K991903EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)2Cleared 510(K)
- K971214KILOWIN2Cleared 510(K)
- K932571TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-42Cleared 510(K)
- K903734ADVANTAGE EP2Cleared 510(K)
- K883914FATIGMETER2Cleared 510(K)
- K880593TECA/MEDELEC MISTRAL2Cleared 510(K)
- K874136PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL2Cleared 510(K)
- K872725MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM2Cleared 510(K)
- K861069TECA NEUROPTO WITH OS-5 STIMULATOR2Cleared 510(K)
- K860910V100 VISUALLY EVOKED POTENTIAL MONITOR2Cleared 510(K)
- K860801MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)2Cleared 510(K)
- K863956MACULOSCOPE(TM)2Cleared 510(K)
- K854362MODIFIED BRAIN ATLAS III2Cleared 510(K)
- K852533L.E.D. GOGGLES, MODEL 580-LEDGOG2Cleared 510(K)
- K853412WAVE GATE2Cleared 510(K)
- K844659VPS 2250, CSU2250 & VFU 22502Cleared 510(K)
- K844616SIEGEN VISUAL STIMULATOR2Cleared 510(K)
- K842964PHOTIC STIMULATOR TM-3030-702Cleared 510(K)
- K842381SLS 3500 LED VISUAL STIMULATOR2Cleared 510(K)
- K834442LED STIMULATOR LS-052Cleared 510(K)
- K831651EVOKED POTENTIAL SYSTEM 20002Cleared 510(K)
- K832084EVOKED 3500 POTENTIAL SYSTEM2Cleared 510(K)
- K831047BIOLOGIC SYSTEM BL 1012Cleared 510(K)
- K812061MODEL S10VS VISUAL STIMULATOR2Cleared 510(K)
- K810481VISUAL PATTERN REVERSAL GEN. & PHOTIC S.2Cleared 510(K)
- K801671ESG-1 (EVOKED RESPONSE STIMULUS GENER)2Cleared 510(K)
- K791149STIMULATOR MODEL SSS-11012Cleared 510(K)
- K790570STIMULATOR, NIC-106 VISUAL2Cleared 510(K)
- K790217GENERATOR, MODEL VG-12Cleared 510(K)
- K781461MODEL 7320 VISUAL STIMULATOR2Cleared 510(K)
- K781398TECA VS6 VIDEO STIMULATOR2Cleared 510(K)
- 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
- 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
ENFANTTM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K043491
- 510(k) Type
- Traditional
- Applicant
- DIOPSYS INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/16/2005
- Days to Decision
- 89 days
- Submission Type
- Summary