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
- K243749Jmoon Conductive Gel2Cleared 510(K)
- K220735Avologi Gel Primer (Model: Av25)2Cleared 510(K)
- K222770Conductive Gel2Cleared 510(K)
- K221724Conductive Gel2Cleared 510(K)
- K212325EEG-acp2Cleared 510(K)
- K212326AC Cream - Conductive paste2Cleared 510(K)
- K212787GT5 conductive & abrasive gel2Cleared 510(K)
- K200402DR-HO'S Electro Therapy Conductive Gel2Cleared 510(K)
- K191975Elefix V Paste for EEG & EMG2Cleared 510(K)
- K192606SAC2 - Electrode Cream2Cleared 510(K)
- K190050Tech Dots - Adhesive and conductive gel2Cleared 510(K)
- K161715EndyGel2Cleared 510(K)
- K161654NuFACE Gel Primer2Cleared 510(K)
- K111717ELECTRO-GEL2Cleared 510(K)
- K032239THERA-CREAM, MODEL TCT0042Cleared 510(K)
- K033052CONDUCTIVE EEG ELECTROLYTE2Cleared 510(K)
- K030887LEKTROGEL, MODEL LK30012Cleared 510(K)
- K022494HOME CARE JELLY2Cleared 510(K)
- K022006CONDUCTIVE GEL2Cleared 510(K)
- K003924MAVIDON MEDICAL ELECTRODE JELLY2Cleared 510(K)
- K002832CONDUCTIVE GEL FOR ULTRASOUND2Cleared 510(K)
- K001705STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF2Cleared 510(K)
- K983964BATCH #6060 CONDUCTIVE GEL2Cleared 510(K)
- K970694MODEL 1700, HYDRO PREP2Cleared 510(K)
- K964737HYDROPREP GEL2Cleared 510(K)
- K962681ECOGEL 300 TENS GEL2Cleared 510(K)
- K955597MEDI-TRACE DEFIB PADS2Cleared 510(K)
- K944598GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL2Cleared 510(K)
- K944599GRAHAM-FIELD CONDUCTIVE ECG SPRAY2Cleared 510(K)
- K944600GRAHAM-FIELD SALINE ELECTROLYTE GEL2Cleared 510(K)
- K933799TEN-20 CONDUCTIVE PASTE GEL2Cleared 510(K)
- K933797OMNI PREP GEL2Cleared 510(K)
- K933804LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL2Cleared 510(K)
- K925466CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON2Cleared 510(K)
- K904377ELECTROCONDUCTIVE MEDIA2Cleared 510(K)
- K904889TENS CONDUCTIVE MEDIA PAD2Cleared 510(K)
- K901630CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)2Cleared 510(K)
- K893604TENS PREP2Cleared 510(K)
- K883149TEN20 CONDUCTIVE2Cleared 510(K)
- K872045CONDUCTIVITY GEL2Cleared 510(K)
- K871913CONDUCTIVITY GEL2Cleared 510(K)
- K862799SKIN PURE2Cleared 510(K)
- K860210ELEFIX ELECTRODE CREAM2Cleared 510(K)
- K852956CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION2Cleared 510(K)
- K841871LIQUA-SONIC GEL2Cleared 510(K)
- K833172ECG-GEL ELECTRODE GEL2Cleared 510(K)
- K821539MEDICOTEST ELECTRODE PASTE2Cleared 510(K)
- K820991KENZ-GELECT GEL PAD2Cleared 510(K)
- K812263KENZ-GELECT2Cleared 510(K)
- K812284ZEE ELECTRODE-GEL2Cleared 510(K)
- K802647ECA GEL PROUDUCT REFORMULATION2Cleared 510(K)
- K803151ECG & ULTRASOUND GELS, CREAMS & LOTION2Cleared 510(K)
- K802658RODEL ELECTRODERM PADS2Cleared 510(K)
- K802648UCA CREAM PRODUCT REFORMULATION2Cleared 510(K)
- K802649UCA GEL PRODUCT REFORMAULATION2Cleared 510(K)
- K802650UCA LOTION PRODUCT REFORMULATION2Cleared 510(K)
- K801383ECA CREAM REFORMULATION2Cleared 510(K)
- K792491ECA CREAM2Cleared 510(K)
- K792488ECA GEL2Cleared 510(K)
- K791013SPECTRA R PAD2Cleared 510(K)
- K790818MEDI-TRACE EEG CREME2Cleared 510(K)
- K781493EEG GEL2Cleared 510(K)
- K782055CREAM, SIGNA2Cleared 510(K)
- K781989OMNIPREP2Cleared 510(K)
- K780973SIGNAPAD2Cleared 510(K)
- K780631NDM INFANT ECG PACKPAD2Cleared 510(K)
- K771893DISPOSABLE ELHCTRODE2Cleared 510(K)
- K770623CONDUCTIVE CREAM-5002Cleared 510(K)
- K770622CONDUCTIVITY GEL W/POTASSIUM CHLORIDE2Cleared 510(K)
- 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
SKIN PURE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K862799
- 510(k) Type
- Traditional
- Applicant
- NIHON KOHDEN AMERICA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/13/1986
- Days to Decision
- 114 days