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
- K240189NM-01/CPT neurometer (NM-01/CPT)2Cleared 510(K)
- K190536Mediracer NCS2Cleared 510(K)
- K070109NEUROMETRIX ADVANCE2Cleared 510(K)
- K060584NC-STAT2Cleared 510(K)
- K053058XLTEK NEUROPATH, MODEL PK10702Cleared 510(K)
- K052904VIRTUAL MEDICAL SYSTEMS MODEL VT30002Cleared 510(K)
- K041320MODIFICATION TO NC-STAT2Cleared 510(K)
- K013459MODIFICATION OF NC-STAT2Cleared 510(K)
- K012069MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT2Cleared 510(K)
- K003508NC-STAT2Cleared 510(K)
- K001692NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 82Cleared 510(K)
- K000565MODIFICATION TO NC-STAT2Cleared 510(K)
- K982359NC-STAT2Cleared 510(K)
- K963208NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)2Cleared 510(K)
- K935298INSTA-NERVE(TM) NERVE CONDUCTION MONITOR2Cleared 510(K)
- K935017TD50 ELECTROMYOGRAPH2Cleared 510(K)
- K932533SMARTSCOPE2Cleared 510(K)
- K923665REUSABLE DUAL DISC BAR RECORDING ELECTRODES2Cleared 510(K)
- K921504REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS2Cleared 510(K)
- K904165SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT2Cleared 510(K)
- K900378EMG OPTION FOR MICROSHEV 40002Cleared 510(K)
- K884663IMPULSE EPIDURAL ELECTRODE2Cleared 510(K)
- K843924DIGITAL ELECTRONEUROMETER S-1002Cleared 510(K)
- K844681EMG REPORT GENERATOR2Cleared 510(K)
- K844216GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR2Cleared 510(K)
- K820031CADWELL 52002Cleared 510(K)
- K760689NERVEL-NERVE CONDUCTION VELOCITY METER2Cleared 510(K)
- 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
SMARTSCOPE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K932533
- 510(k) Type
- Traditional
- Applicant
- INSIGHT MEDICAL CORP.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/31/1994
- Days to Decision
- 309 days
- Submission Type
- Statement