Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
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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
- 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
- K242447Falcon HST2Cleared 510(K)
- K241288Noxturnal Web2Cleared 510(K)
- K240700HomeSleepTest (HST, HST REM+)2Cleared 510(K)
- K213007Cerebra Sleep System2Cleared 510(K)
- K201054SOMNOscreen plus2Cleared 510(K)
- K192624ApneaTrak2Cleared 510(K)
- K181709Serenity Piezo Sensor, Serenity Thermocouple Sensor2Cleared 510(K)
- K173868Serenity Body Position Sensor, Serenity RIP Sensors2Cleared 510(K)
- K173690Grass TWin2Cleared 510(K)
- K172986Zmachine Synergy2Cleared 510(K)
- K172711Comet-PLUS2Cleared 510(K)
- K161650Polysmith Sleep System, Model NTI75932Cleared 510(K)
- K142774Polysmith Sleep System2Cleared 510(K)
- K131415LIVE VIEW PANEL (LVP)2Cleared 510(K)
- K111055GALAXY SYSTEM; JUPITER2Cleared 510(K)
- K101830ZMACHINE, MODEL DT-1002Cleared 510(K)
- K093728BE MICRO, TREA2Cleared 510(K)
- K073491EEG-1100A SWITCH BOX2Cleared 510(K)
- K071782MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES2Cleared 510(K)
- K050425AURA-PSG2Cleared 510(K)
- K052066CEEGRAPH/SLEEPSCAN NETLINK TRAVELER2Cleared 510(K)
- K050833ELECTRODE JUNCTION BOX, MODEL JE-921A2Cleared 510(K)
- K050143OMNIPRO SYSTEM2Cleared 510(K)
- K042039FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 1202Cleared 510(K)
- K042364PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES2Cleared 510(K)
- K033475WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES2Cleared 510(K)
- K031202MEDIPALM-202Cleared 510(K)
- K022249NIGHTRON POLYSOMNOGRAPHY SYSTEM2Cleared 510(K)
- K022037XLTEK SLEEP SYSTEM2Cleared 510(K)
- K021807GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM2Cleared 510(K)
- K022121PSG INPUT BOX, MODEL JE-912AK2Cleared 510(K)
- K021185NERVUS MONITOR2Cleared 510(K)
- K012976TWIN PLUS2Cleared 510(K)
- K013450NOTTA AMBULATORY RECORDER2Cleared 510(K)
- K012085SOMNO STAR & SERIES SLEEP SYSTEM2Cleared 510(K)
- K010728HARMONE-SCHWARZER EEG SYSTEM2Cleared 510(K)
- K010460LIFELINES TRACKIT2Cleared 510(K)
- K011204NEUROFAX, MODELS EEG-1100A, EEG-9100A2Cleared 510(K)
- K003175COMPUMEDICS SIESTA SYSTEM2Cleared 510(K)
- K003681BIO-LOGIC SLEEPSCAN NETLINK2Cleared 510(K)
- K001013MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY2Cleared 510(K)
- K000338VITAPORT 32Cleared 510(K)
- K994142GRASS TS3201/6401 EEG AMPLIFIER SYSTEM2Cleared 510(K)
- K992742NEUROFAX, MODEL EEG-1100A2Cleared 510(K)
- K992283ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY2Cleared 510(K)
- K992291H20- TETHERED OPTION2Cleared 510(K)
- K991446BIOSACA SYSTEM, MODEL 8002Cleared 510(K)
- K991900XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-402Cleared 510(K)
- K990522WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS2Cleared 510(K)
- K984580BIOSACA SYSTEM2Cleared 510(K)
- K983072AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR32012Cleared 510(K)
- K983913MODIFICATION TO BIO-LOGIC SLEEPSCAN2Cleared 510(K)
- K974583DEEGLITE2Cleared 510(K)
- K974587H2O2Cleared 510(K)
- K971813EMBLA2Cleared 510(K)
- K971867ALICE 4R SYSTEM2Cleared 510(K)
- K970951GRASS BRAINWAVE SOFTWARE2Cleared 510(K)
- K961638MEDILOG MPA-S2Cleared 510(K)
- K922106ALICE2Cleared 510(K)
- K934599SANDMAN2Cleared 510(K)
- K860458ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP.2Cleared 510(K)
- K8546654312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH2Cleared 510(K)
- K860219SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM2Cleared 510(K)
- 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
Polysmith Sleep System, Model NTI7593
- Page Type
- Cleared 510(K)
- 510(k) Number
- K161650
- 510(k) Type
- Traditional
- Applicant
- Neurotronics, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/19/2017
- Days to Decision
- 218 days
- Submission Type
- Summary