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
- K243982Nicolet EDX2Cleared 510(K)
- K243495Natus Ultrapro S100 (982A0594)2Cleared 510(K)
- K242345Delphi Stimulator2Cleared 510(K)
- K234092SafeOp 3: Neural Informatix Systeem2Cleared 510(K)
- K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)2Cleared 510(K)
- K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress2Cleared 510(K)
- K230415Cadwell Guardian2Cleared 510(K)
- K213849SafeOp 2: Neural Informatix System2Cleared 510(K)
- K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress2Cleared 510(K)
- K192823MEGA-TMS2Cleared 510(K)
- K190703Neuro-IOM system with Neuro-IOM.NET software2Cleared 510(K)
- K200759NIM Vital, Nerve Integrity Monitor2Cleared 510(K)
- K182542The EPAD 2 System2Cleared 510(K)
- K170677Neurovision Nerve Locator Monitor (Nerveana), EMGView Software2Cleared 510(K)
- K162873MEP Monitor2Cleared 510(K)
- K162199Cascade IOMAX Intraoperative Monitor2Cleared 510(K)
- K160280MagPro R202Cleared 510(K)
- K150220STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast2Cleared 510(K)
- K142624Neuromaster G1 MEE2002Cleared 510(K)
- K132616EPAD2Cleared 510(K)
- K130403MAGSTIM DOUBLE 70-2 COIL2Cleared 510(K)
- K123843NEUROEPG SYSTEM2Cleared 510(K)
- K130346SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION2Cleared 510(K)
- K120397MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM2Cleared 510(K)
- K112881NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)2Cleared 510(K)
- K120979CAREFUSION NICOLET EDX2Cleared 510(K)
- K112052CAREFUSION NICOLET EDX2Cleared 510(K)
- K111647C2 NERVEMONITOR SYSTEM WITH ACCESSORIES2Cleared 510(K)
- K110140NEUROVISION NERVE LOCATOR MONITOR2Cleared 510(K)
- K093304PROTEKTOR 322Cleared 510(K)
- K094054MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE2Cleared 510(K)
- K091940MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION2Cleared 510(K)
- K091457NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM2Cleared 510(K)
- K083371NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)2Cleared 510(K)
- K090298NUVASIVE NEURO VISION SYSTEM2Cleared 510(K)
- K082614EVOX ELECTRO DIAGNOSTIC DEVICE2Cleared 510(K)
- K083124NIM 3.02Cleared 510(K)
- K080499MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-002Cleared 510(K)
- K071969SEN-4100 ELECTRIC STIMULATOR2Cleared 510(K)
- K072343NEUROVISION JJB SYSTEM2Cleared 510(K)
- K071821COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B652Cleared 510(K)
- K062765MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM2Cleared 510(K)
- K061639ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON2Cleared 510(K)
- K061645MAGPRO, MODEL R302Cleared 510(K)
- K060847MAGSTIM 200-22Cleared 510(K)
- K061113ORTHOMON2Cleared 510(K)
- K051864MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-002Cleared 510(K)
- K051357DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH2Cleared 510(K)
- K051178MEE-1000A NEUROMASTER2Cleared 510(K)
- K050798ECLIPSE NEUROLOGICAL WORKSTATION2Cleared 510(K)
- K051384MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM2Cleared 510(K)
- K030526PEDIGUARD NERVE DETECTOR SYSTEM2Cleared 510(K)
- K042350TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR2Cleared 510(K)
- K040358XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 102482Cleared 510(K)
- K031930HIGH SPEED EMG MODULE2Cleared 510(K)
- K032741EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION2Cleared 510(K)
- K020400DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR2Cleared 510(K)
- K010092XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)2Cleared 510(K)
- K010090XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)2Cleared 510(K)
- K010087XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP2Cleared 510(K)
- K002969XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-82Cleared 510(K)
- K002773NEUROMAP WITH NEURO 1002Cleared 510(K)
- K000963DA VINCHI EEG AND EMG/EP SYSTEMS2Cleared 510(K)
- K001101XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-42Cleared 510(K)
- K992911MAGSTIM RAPID2Cleared 510(K)
- K991899NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES2Cleared 510(K)
- K992313XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-162Cleared 510(K)
- K981405SYNERGY LT2Cleared 510(K)
- K980866MEDI-DX 7000 CPT WITH AMREX ELECTRODES2Cleared 510(K)
- K971740AMPLAID MK122Cleared 510(K)
- K972959AMPLAID MK222Cleared 510(K)
- K971819EPOCH 2000 NEUROLOGICAL WORKSTATION2Cleared 510(K)
- K965065TECA. MILLENNIUM2Cleared 510(K)
- K963662GALILEO EVOKED POTENTIALRE2Cleared 510(K)
- K962457TWO-CHANNEL PREAMPLIFIER2Cleared 510(K)
- K962458CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER2Cleared 510(K)
- K962455FOUR-CHANNEL PREAMPLIFIER2Cleared 510(K)
- K932994EVOKED POTENTIAL SYSTEM-1.02Cleared 510(K)
- K960170ELECTROENCEPHALOGRAPH (EEG)2Cleared 510(K)
- K955257SS102 DUAL CHANNEL SEP STIMULATOR2Cleared 510(K)
- K952294NEURONET2Cleared 510(K)
- K944547DANTEC KEYPOINT2Cleared 510(K)
- K950208NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM2Cleared 510(K)
- K931923DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)2Cleared 510(K)
- K926516DANTEC MAGNETIC STIMULATOR MAGPRO2Cleared 510(K)
- K931428CADWELL 6200 A2Cleared 510(K)
- K924723CADWELL SIERRA2Cleared 510(K)
- K924127DANTEC EVOLUTION2Cleared 510(K)
- K923303SAPPHIRE PREMIERE2Cleared 510(K)
- K923315NICOLET ARK SYSTEM2Cleared 510(K)
- K912685MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS2Cleared 510(K)
- K915652NICOLET PORATBLE SPIRIT SYSTEM2Cleared 510(K)
- K912775SAPPHIRE 4ME EMG/EP SYSTEM2Cleared 510(K)
- K905059HIGH SPEED MAGNETIC STIMULATOR2Cleared 510(K)
- K902607DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)2Cleared 510(K)
- K903731SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME2Cleared 510(K)
- K894560QSI 90002Cleared 510(K)
- K900482SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG2Cleared 510(K)
- K896567CANTATA EMG/EVOKED RESPONSE SYSTEM2Cleared 510(K)
- K894608MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM2Cleared 510(K)
- K890274MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR2Cleared 510(K)
- K885246ADVANTAGE2Cleared 510(K)
- K884870TECA/MEDELEC 'CONCEPT' P4202Cleared 510(K)
- K883340NEURAL MAGNETIC STIMULATOR, THE D1902Cleared 510(K)
- K881915DANTEC MAGNETIC STIMULATOR2Cleared 510(K)
- K880088CADWELL EXCEL2Cleared 510(K)
- K870567EVOPORT 3002Cleared 510(K)
- K871964SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.2Cleared 510(K)
- K872106DANTEC COUNTERPOINT2Cleared 510(K)
- K871338NOVAMETRIX MODEL 200 MAGSTIM2Cleared 510(K)
- K863175EES 10 ELECTRODELESS ELECTRICAL STIMULATOR2Cleared 510(K)
- K862690TRAVELER LT2Cleared 510(K)
- K861900LIFESCAN EVOKED POTENTIAL SYSTEM2Cleared 510(K)
- K860968TM-3400, NOMAD (MODIFIED)2Cleared 510(K)
- K855232SOMATOSENSORY EVOKED POTENTIAL STIMULATOR2Cleared 510(K)
- K860903TM-3600 A NEURODIAGNOSTIC SYSTEM2Cleared 510(K)
- K860240CNS-EP SYSTEM AND EP 1.0 SOFTWARE2Cleared 510(K)
- K851300NEUROPACK 8, MEE-41082Cleared 510(K)
- K844992BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM2Cleared 510(K)
- K850109NOMAD TM-34002Cleared 510(K)
- K843815EVOMATIC 8000/40002Cleared 510(K)
- K844707QUANTUM 842Cleared 510(K)
- K843712AUDIT TM V2Cleared 510(K)
- K842543EVOKED POTENTIAL SYS2Cleared 510(K)
- K843464SIEGEN NEUROSCOPE2Cleared 510(K)
- K843253EMG/NCV & EVOKED RESPONSE, DESIGN W/2Cleared 510(K)
- K831896COMPACT FOUR2Cleared 510(K)
- K830771CADWELL 84002Cleared 510(K)
- K822744#ST10 PROGR. EVOKED RESPONSE STIMULATOR2Cleared 510(K)
- K822396THE 35002Cleared 510(K)
- K822214CADWELL 74002Cleared 510(K)
- K820908TECA MODEL SENSOR ER 942Cleared 510(K)
- K820414UNIVERSAL TESTING & ANALYSIS SYSTEMS2Cleared 510(K)
- K811848MODEL SIX BEAM SYSTEM2Cleared 510(K)
- K810482SOMATOSENSORY STIMULATOR2Cleared 510(K)
- K810560TN-3000 EVOKED RESPONSE SYSTEM2Cleared 510(K)
- K781704STIMULATOR, TN-3001 SOMATOSENSORY2Cleared 510(K)
- K780539STIMULATOR MODEL 80212Cleared 510(K)
- 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
SAPPHIRE PREMIERE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K923303
- 510(k) Type
- Traditional
- Applicant
- MEDELEC LTD.
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/24/1992
- Days to Decision
- 141 days
- Submission Type
- Statement