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
- K241045Disposable Subdermal Needle Electrode, Corkscrew2Cleared 510(K)
- K232581Medical Disposable Sterile Needle Electrode2Cleared 510(K)
- K231691Phantom XL Insulated Dilators2Cleared 510(K)
- K200984Guardian Needle Electrode2Cleared 510(K)
- K192603Spes Medica Subdermal Needle Electrodes2Cleared 510(K)
- K190801PressOn Electrode Headset2Cleared 510(K)
- K161566DMS Disposable Subdermal Needle Electrodes2Cleared 510(K)
- K142470E-Shield Multi-paried Subdermal Needle Electrodes2Cleared 510(K)
- K140200E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES2Cleared 510(K)
- K130220MR CONDITIONAL PRESSON ELECTRODE2Cleared 510(K)
- K130136DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,2Cleared 510(K)
- K121347PRESSON ELECTRODE2Cleared 510(K)
- K103103PRESSON ELECTRODE2Cleared 510(K)
- K110419AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS2Cleared 510(K)
- K100912DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE2Cleared 510(K)
- K073229NERVE MONITORING CABLE2Cleared 510(K)
- K072276SUBDERMAL NEEDLE ELECTRODES2Cleared 510(K)
- K063729DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-002Cleared 510(K)
- K071185MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE2Cleared 510(K)
- K062996DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES2Cleared 510(K)
- K062880SUBDERMAL WIRE ELECTRODE, MODEL SWE2Cleared 510(K)
- K060189PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)2Cleared 510(K)
- K052111XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 1023822Cleared 510(K)
- K050325DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE2Cleared 510(K)
- K050194AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES2Cleared 510(K)
- K040639ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE2Cleared 510(K)
- K023472LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-8122Cleared 510(K)
- K022914RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES2Cleared 510(K)
- K020910SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF2Cleared 510(K)
- K021118DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-5702Cleared 510(K)
- K010019STERILE SUBDERMAL NEEDLE ELECTRODES2Cleared 510(K)
- K990100POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE2Cleared 510(K)
- K990793ACCUGUIDE MUSCLE INJECTION MONITOR2Cleared 510(K)
- K983597NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES2Cleared 510(K)
- K974119DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)2Cleared 510(K)
- K950314DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)2Cleared 510(K)
- K926094PROTECTRODE SYSTEM2Cleared 510(K)
- K934779AGRAM SPYRAL ELECTRODE2Cleared 510(K)
- K933796EEG NEEDLE ELECTRODE2Cleared 510(K)
- K933795CONCENTRIC EMG NEEDLE ELECTRODE2Cleared 510(K)
- K933806MONOPOLAR EMG NEEDLE ELECTRODE2Cleared 510(K)
- K933793GROUND/REFERENCE NEEDLE ELECTRODE2Cleared 510(K)
- K926349PROBLOC INSULATED NEEDLES2Cleared 510(K)
- K920352BIO-DETEK EEG ELECTRODE2Cleared 510(K)
- K912783DISPOSABLE MONOPOLAR NEEDLE ELECTRODE2Cleared 510(K)
- K894911SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,1182Cleared 510(K)
- K901280DISPOSIBLE EEG NEEDLE ELECTRODES2Cleared 510(K)
- K900740SPECIMEX DC2Cleared 510(K)
- K896370DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)2Cleared 510(K)
- K863135LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)2Cleared 510(K)
- K863136HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP)2Cleared 510(K)
- K850107CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE2Cleared 510(K)
- K781311ELECTRODE, NEEDLE, CFM2Cleared 510(K)
- 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
- 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
PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K060189
- 510(k) Type
- Traditional
- Applicant
- IVES EEG SOLUTIONS, INC.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/30/2006
- Days to Decision
- 126 days
- Submission Type
- Statement