Anesthesiology
Review 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
- OLWIndex-Generating Electroencephalograph Software2Product Code
- K230693BIS™ Advance Monitoring System2Cleared 510(K)
- K213273Brain Anesthesia Response Monitor (Bar Monitor)2Cleared 510(K)
- K203113Masimo SedLine Sedation Monitor and Accessories2Cleared 510(K)
- K202621NeuroSENSE Monitoring System, Model NS-9012Cleared 510(K)
- K172890SedLine Sedation Monitor2Cleared 510(K)
- K150298Entropy Module, E-ENTROPY-012Cleared 510(K)
- K083063BIS INTERFACE FOR VITALOGIK PATIENT MONITORS2Cleared 510(K)
- K061907MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES2Cleared 510(K)
- K072286BIS EEG VISTA MONITOR SYSTEM AND BISX2Cleared 510(K)
- K071899BIS MODULE FOR ENVOY PATIENT MONITOR2Cleared 510(K)
- K062613BIS EEG MONITOR VIEW2Cleared 510(K)
- K060900SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-918422Cleared 510(K)
- K060997SNAP II EEG MONITOR2Cleared 510(K)
- K052981BIS EEG MONITOR, MODEL BISX42Cleared 510(K)
- K052362BIS EEG MONITOR, MODEL A-30002Cleared 510(K)
- K051874SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET2Cleared 510(K)
- K052145DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES2Cleared 510(K)
- K050835DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES2Cleared 510(K)
- K042315CEREBRAL STATE MONITOR - CSM2Cleared 510(K)
- K033543NARCOTREND, MODEL COMPACT 4.02Cleared 510(K)
- K040183BISX2Cleared 510(K)
- K033999SEDLINE WITH FRONTAL PSI2Cleared 510(K)
- K030267EEG MONITOR WITH BIS, MODEL A-20002Cleared 510(K)
- K031694MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-20002Cleared 510(K)
- K023459DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES2Cleared 510(K)
- K020671PSA4000 EEG MONITOR WITH FRONTAL PSI2Cleared 510(K)
- K020218SNAP EEG MONITOR2Cleared 510(K)
- K013389DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES2Cleared 510(K)
- K012466BIS/EEG MODULE2Cleared 510(K)
- K011834BIS ENGINE2Cleared 510(K)
- K010965A-LINE AEP MONITOR2Cleared 510(K)
- K011534EEG MIS MONITOR MODEL # A-2000; BIS ENGINE2Cleared 510(K)
- K003038AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A2Cleared 510(K)
- K002837BIS ENGINE2Cleared 510(K)
- K001069MODEL 4000 EEG MONITOR WITH PSI (PSA4000)2Cleared 510(K)
- K974496A-2000 EEG MONITOR WITH BIS2Cleared 510(K)
- K973596SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE2Cleared 510(K)
- K963644A-1000 EEG MONITOR AND A-1050 EEG MONITOR2Cleared 510(K)
- 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
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- PathologyReview Panel
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- UnknownReview Panel
BIS ENGINE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K011834
- 510(k) Type
- Special
- Applicant
- ASPECT MEDICAL SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/10/2001
- Days to Decision
- 28 days
- Submission Type
- Summary