Anesthesiology
Review Panel
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- Cardiovascular Diagnostic DevicesCFR Sub-Part
- Cardiovascular Monitoring DevicesCFR Sub-Part
- Cardiovascular Therapeutic DevicesCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- 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
- OMCReduced- Montage Standard Electroencephalograph2Product Code
- K203827REMI2Cleared 510(K)
- K192549Byteflies Kit2Cleared 510(K)
- K183529AE-120A EEG Head Set2Cleared 510(K)
- K170363Ceribell Pocket EEG Device2Cleared 510(K)
- K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)2Cleared 510(K)
- K131944IEEG2Cleared 510(K)
- K130013X4 SYSTEM2Cleared 510(K)
- K120447X42Cleared 510(K)
- K110967ENTERPRISE ELECTROPHYSIOLOGY SYSTEM2Cleared 510(K)
- K092477NEUROSENSE MONITORING SYSTEM, MODEL NS-7012Cleared 510(K)
- K060523NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM2Cleared 510(K)
- K042309BIOSOMNIA-V32Cleared 510(K)
- K024245ENVOY PATIENT MONITOR2Cleared 510(K)
- K021485BIOSOMNIA2Cleared 510(K)
- K020335OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 53302Cleared 510(K)
- K013863CRYSTAL MONITOR MODEL 162Cleared 510(K)
- K001110CRYSTAL-EEG MODEL 152Cleared 510(K)
- K970672CRYSTAL-EEG MODEL 10 (MODEL 10)2Cleared 510(K)
- K781130ACCESSORY TO ECG ANALYSIS SYS.2Cleared 510(K)
- 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
- OPTInfrared Hematoma Detector2Product Code
- Neurological Surgical DevicesCFR Sub-Part
- Neurological Therapeutic DevicesCFR Sub-Part
- Physical Medicine Diagnostic DevicesCFR Sub-Part
- Physical Medicine Prosthetic DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- 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
ENVOY PATIENT MONITOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K024245
- 510(k) Type
- Traditional
- Applicant
- MENNEN MEDICAL LTD.
- Country
- Israel
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/10/2004
- Days to Decision
- 504 days
- Submission Type
- Summary