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
- 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
- K251881HippoMind (v1.0)2Cleared 510(K)
- K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)2Cleared 510(K)
- K240593VEEGix EEG System2Cleared 510(K)
- K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET Software2Cleared 510(K)
- K213299Wireless EEG System2Cleared 510(K)
- K191322E-EEGX, N-EEGX2Cleared 510(K)
- K192572CNS Envision2Cleared 510(K)
- K190760Cadwell Bolt Software2Cleared 510(K)
- K143487Lifelines iEEG2Cleared 510(K)
- K142834DiscoverEEG System, Model DE-4012Cleared 510(K)
- K133995NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE2Cleared 510(K)
- K142064GALILEO NT2Cleared 510(K)
- K141316COGNISION EEG/EP SYSTEM2Cleared 510(K)
- K131882GEODESICEEG SYSTEM 400 SERIES (GES 400)2Cleared 510(K)
- K123665LIFELINES IEEG2Cleared 510(K)
- K091963VIGILANT EEG MONITOR, VIGILANT 2.02Cleared 510(K)
- K082886ZOOM-100DC2Cleared 510(K)
- K080546NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A2Cleared 510(K)
- K072382MODEL I-2000 MONITOR2Cleared 510(K)
- K063797GEODESIC EEG SYSTEM 3002Cleared 510(K)
- K062533BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 15242Cleared 510(K)
- K051883DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.2Cleared 510(K)
- K033010BRM2 BRAIN MONITOR2Cleared 510(K)
- K030489BRM2 BRAIN MONITOR2Cleared 510(K)
- K023536NUAMPS2Cleared 510(K)
- K001564SCAN LT40 (40 CHANNELS)2Cleared 510(K)
- K001324SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)2Cleared 510(K)
- K000892DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES2Cleared 510(K)
- K000068COMPUMEDICS E-SERIES EEG SYSTEM2Cleared 510(K)
- K991012SIEMENS INFINITY EEG POD2Cleared 510(K)
- K982351LUNA2Cleared 510(K)
- K955577ECLIPSE VERSION 3.02Cleared 510(K)
- K954157DG PORTABLE SYSTEM2Cleared 510(K)
- K952347A-1050 EEG MONITOR2Cleared 510(K)
- K953799DG EXAMINER PLUS2Cleared 510(K)
- K951724QUANTITATIVE EEG ANALYSIS SOFTWARE2Cleared 510(K)
- K940811BRAINTRACE2Cleared 510(K)
- K915820NEUROSEARCH-24 OR NRS-242Cleared 510(K)
- K934050TOPOGRAPHIC BRAIN MAPPING OPTION2Cleared 510(K)
- K923043SPECTRAL EEG MONITOR MODEL A10002Cleared 510(K)
- K913051SPECTRAL EEG MONITOR MODEL B5002Cleared 510(K)
- K894889TECA NEUROMAPPER 3862Cleared 510(K)
- K894088TECA NEUROMAPPER 1620, BRAIN MAPPER2Cleared 510(K)
- K874733GUARDIAN, EEG BRAIN MONITORING SYSTEM2Cleared 510(K)
- K863783HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM2Cleared 510(K)
- K863650QUANTIMAP III2Cleared 510(K)
- K860378MIND MAP (20 CHANNEL EEG)2Cleared 510(K)
- K853420CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS2Cleared 510(K)
- K852587CDSA(COLOR DENSITY, SPECTRAL ARRRAY)2Cleared 510(K)
- K850541SLEEP STAGER2Cleared 510(K)
- K843808DUAL CHENNEL BRAIN ACTIVITY MONITOR2Cleared 510(K)
- K841790LIFESCAN EEG MONITOR2Cleared 510(K)
- K820653OTE BIOMEDICA BERG FOURIER ANALYZER2Cleared 510(K)
- K810359ELECTROENCEPHALOMYOGRAPH2Cleared 510(K)
- 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
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K001324
- 510(k) Type
- Traditional
- Applicant
- Neuro Scan Labs
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/11/2000
- Days to Decision
- 76 days
- Submission Type
- Summary