Anesthesiology
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- 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
- K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)2Cleared 510(K)
- K242618Layer 7-T2Cleared 510(K)
- K221123WISE Cortical Strip (WCS)2Cleared 510(K)
- K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid2Cleared 510(K)
- K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)2Cleared 510(K)
- K191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)2Cleared 510(K)
- K191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode2Cleared 510(K)
- K192764NeuroOne Cortical Electrode2Cleared 510(K)
- K183437AirRay Subdural Cortical Electrodes2Cleared 510(K)
- K180761SD LTM STIM Cortical Stimulator2Cleared 510(K)
- K173684g.Estim PRO2Cleared 510(K)
- K151354Cervello STIM2Cleared 510(K)
- K110410MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)2Cleared 510(K)
- K102802INTEGRA ELECTRODE TUNNELING NEEDLE2Cleared 510(K)
- K082629S12X WITH ESAX OPTION2Cleared 510(K)
- K082474PMT SUBDURAL CORTICAL ELECTRODES2Cleared 510(K)
- K072964NICOLET CORTICAL STIMULATOR2Cleared 510(K)
- K082250AURAGEN CORTICAL SURFACE ELECTRODES2Cleared 510(K)
- K053363DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES2Cleared 510(K)
- K021144SUBDURAL STRIP ELECTRODE2Cleared 510(K)
- K992194CORTICAL MAPPING UNIT, MODEL CMU2Cleared 510(K)
- K961942EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI2Cleared 510(K)
- K970587AD-TECH SUBDURAL ELECTRODE2Cleared 510(K)
- K964224STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE2Cleared 510(K)
- K926424CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON2Cleared 510(K)
- K923330THE WESTERN CORTICAL ELECTRODE ARRAY2Cleared 510(K)
- K924226OJEMANN CORTICAL STIMULATOR2Cleared 510(K)
- K923803AD-TECH SUB DURAL ELECTRODEDS2Cleared 510(K)
- K912760AD-TECH EPIDURAL PEG ELECTRODE2Cleared 510(K)
- K882053NICOLET EPIDURAL SPINAL ELECTRODE2Cleared 510(K)
- K850342WYLER SUBDURAL STRIP ELECTRODE2Cleared 510(K)
- K845035ELECTRODE FOR NEUROLOGICAL SURGERY 21112Cleared 510(K)
- 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
g.Estim PRO
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K173684
- 510(k) Type
- Traditional
- Applicant
- G.Tec Medical Engineering GmbH
- Country
- Australia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/4/2018
- Days to Decision
- 154 days
- Submission Type
- Summary