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
- 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
- K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))2Cleared 510(K)
- K243743autoSCORE (V 2.0.0)2Cleared 510(K)
- K241589Ceribell Seizure Detection Software2Cleared 510(K)
- K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))2Cleared 510(K)
- K241390NeuroMatch2Cleared 510(K)
- K240408REMI-AI Rapid Detection Module (REMI-AI RDM)2Cleared 510(K)
- K240993encevis (2.1)2Cleared 510(K)
- K231068autoSCORE2Cleared 510(K)
- K231779REMI AI Discrete Detection Module2Cleared 510(K)
- K222450LVIS NeuroMatch2Cleared 510(K)
- K223504Ceribell Status Epilepticus Monitor2Cleared 510(K)
- K222002Persyst 15 EEG Review and Analysis Software2Cleared 510(K)
- K211452Encevis2Cleared 510(K)
- K200878Natus NeuroWorks2Cleared 510(K)
- K191301Ceribell Pocket EEG Device2Cleared 510(K)
- K182181Persyst 14 EEG Review and Analysis Software2Cleared 510(K)
- K171720encevis2Cleared 510(K)
- K180421Natus NeuroWorks2Cleared 510(K)
- K171184Persyst Mobile App2Cleared 510(K)
- K150688IdentEvent2Cleared 510(K)
- K151929PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE2Cleared 510(K)
- K141883CLINISCANSM EEG2Cleared 510(K)
- K140552CADWELL SPIKE AND SEIZURE DETECTOR2Cleared 510(K)
- K133793PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE2Cleared 510(K)
- K132306PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE2Cleared 510(K)
- K120260ICTA2Cleared 510(K)
- K090019NATUS NEUROWORKS, MODEL 1041962Cleared 510(K)
- K092039IDENTEVENT, VERSION 1.0G2Cleared 510(K)
- K042223XLTEK CONNEX IP HEADBOX, MODEL 10542Cleared 510(K)
- K011397PERSYST REVEAL2Cleared 510(K)
- K010085EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)2Cleared 510(K)
- K002332EEG SPIKE AND EVENT DETECTOR MODULE2Cleared 510(K)
- K960273HARMONIE SENSA2Cleared 510(K)
- K955787DIGITRACE HOME VIDEO SYSTEM2Cleared 510(K)
- K951594BIO-LOGIC AUTOMATIC EVENT ANALYSIS2Cleared 510(K)
- K950270NMI SOFTWARE2Cleared 510(K)
- K944833DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM2Cleared 510(K)
- K950117PERSYST SPIKE DETECTOR2Cleared 510(K)
- K910771DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX2Cleared 510(K)
- K870450SZAC-16 SEIZURE ANALYSIS COMPUTER2Cleared 510(K)
- 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
IdentEvent
- Page Type
- Cleared 510(K)
- 510(k) Number
- K150688
- 510(k) Type
- Traditional
- Applicant
- OPTIMA NEUROSCIENCE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/5/2015
- Days to Decision
- 233 days
- Submission Type
- Statement