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
- K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept2Cleared 510(K)
- K250601Neuro Omega System; NeuroSmart System2Cleared 510(K)
- K223269Spencer Probe Depth Electrodes2Cleared 510(K)
- K223276Anchor Bolts as Accessories to Depth Electrodes2Cleared 510(K)
- K213170SENSOSEEG Depth Electrodes2Cleared 510(K)
- K222706iCE-SG2 Subcutaneous Electrode Kit2Cleared 510(K)
- K222404Evo® sEEG System2Cleared 510(K)
- K220553Neuro Omega System, NeuroSmart System2Cleared 510(K)
- K202087DIXI Medical Microdeep Micro-Macro Depth Electrodes2Cleared 510(K)
- K211367Evo sEEG System2Cleared 510(K)
- K201678iCE-SG Subcutaneous Electrode Arrays2Cleared 510(K)
- K191739Sterile LeadConfirm2Cleared 510(K)
- K183123microTargeting Guideline 4000 5.0 System2Cleared 510(K)
- K181544Anchor Bolt (as an accessory to Depth Electrodes)2Cleared 510(K)
- K172042NeuroNav System, NeuroSmart System2Cleared 510(K)
- K171581Neuro Omega System2Cleared 510(K)
- K170959DIXI Medical Microdeep Depth Electrode2Cleared 510(K)
- K162459AccuPoint Electrode2Cleared 510(K)
- K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes2Cleared 510(K)
- K151790PMT Platinum Depthalon Depth Electrode2Cleared 510(K)
- K152547DNAP Electrode2Cleared 510(K)
- K140680LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM2Cleared 510(K)
- K123796NEURO OMEGA SYSTEM2Cleared 510(K)
- K120098STERILE DISPOSABLES FOR MER2Cleared 510(K)
- K110010NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM2Cleared 510(K)
- K082404NAVIGATION PROBES2Cleared 510(K)
- K071697NEURONAV SYSTEM AND NEURONAV DRIVE2Cleared 510(K)
- K070272NEUROPORT ELECTRODE2Cleared 510(K)
- K071364MICROTARGETING GUIDELINE 40002Cleared 510(K)
- K053358DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES2Cleared 510(K)
- K052527NEUROPROBES2Cleared 510(K)
- K051830NEURODRIVE SYSTEM2Cleared 510(K)
- K042384NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM2Cleared 510(K)
- K042208ISIS MER SYSTEM/ELEKTA MER SYSTEM2Cleared 510(K)
- K041409MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-2307992Cleared 510(K)
- K041604MACRO-MICRO DEPTH ELECTRODE2Cleared 510(K)
- K033730PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES2Cleared 510(K)
- K033173MICRO TARGETING ELECTRODE2Cleared 510(K)
- K012850RECORDING AND STIMULATING ELECTRODE2Cleared 510(K)
- K991522MICROTARGETING ELECTRODE2Cleared 510(K)
- K993622NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY2Cleared 510(K)
- K990788AD-TECH'S FORAMEN OVALE ELECTRODE2Cleared 510(K)
- K991077MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)2Cleared 510(K)
- K981820NEUROMAP2Cleared 510(K)
- K981015PALI-TRODE2Cleared 510(K)
- K973454AD-TECH'S SPINAL ELECTRODE2Cleared 510(K)
- K970943GUIDELINE SYSTEM2Cleared 510(K)
- K964644AD-TECH'S DEPTH ELECTRODE2Cleared 510(K)
- K970418PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)2Cleared 510(K)
- K946018TENS-IT, FITTRONIC II, (MORE LATER)2Cleared 510(K)
- K944061CUEVA CRANIAL NERVE ELECTRODE2Cleared 510(K)
- K902976MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC2Cleared 510(K)
- K891920AD-TECH'S DEPTH ELECTRODE2Cleared 510(K)
- K861031WYLER SPHENOIDAL ELECTRODE2Cleared 510(K)
- K802249MICROLET FAMILY OF NEEDLE/DEPTH ELECT-2Cleared 510(K)
- K802152PMT DEPTHALON DEPTH #21022Cleared 510(K)
- K802151PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC2Cleared 510(K)
- 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
Sterile LeadConfirm
- Page Type
- Cleared 510(K)
- 510(k) Number
- K191739
- 510(k) Type
- Traditional
- Applicant
- Alpha Omega Engineering Ltd.
- Country
- Israel
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/2/2020
- Days to Decision
- 188 days
- Submission Type
- Summary