BEUDAMED
    Product Code: OLW FDA class 2 21 CFR 882.1400

    Index-Generating Electroencephalograph Software

    Neurology

    The Index-Generating Electroencephalograph Software (product code OLW) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It analyzes electrical activity of the brain by transforming electroencephalograph signals into a dimensionless index number intended for use and interpretation by a qualified clinical user. The device is not eligible for third-party review and is not an implant or life-sustaining device.

    View on FDA
    510(k)s
    38
    FEI Numbers
    38
    Registration Numbers
    38
    Unique Applicants
    18
    Years Active
    27

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    Basic Information

    Product Code
    OLW
    Device Class
    FDA class 2
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 38 510(k) clearances via K numbers.

    K Number Device Name
    K230693 BIS™ Advance Monitoring System
    K213273 Brain Anesthesia Response Monitor (Bar Monitor)
    K203113 Masimo SedLine Sedation Monitor and Accessories
    K202621 NeuroSENSE Monitoring System, Model NS-901
    K172890 SedLine Sedation Monitor
    K150298 Entropy Module, E-ENTROPY-01
    K083063 BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
    K061907 MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
    K072286 BIS EEG VISTA MONITOR SYSTEM AND BISX
    K071899 BIS MODULE FOR ENVOY PATIENT MONITOR
    K062613 BIS EEG MONITOR VIEW
    K060900 SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
    K060997 SNAP II EEG MONITOR
    K052981 BIS EEG MONITOR, MODEL BISX4
    K052362 BIS EEG MONITOR, MODEL A-3000
    K051874 SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET
    K052145 DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
    K050835 DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
    K042315 CEREBRAL STATE MONITOR - CSM
    K033543 NARCOTREND, MODEL COMPACT 4.0
    K040183 BISX
    K033999 SEDLINE WITH FRONTAL PSI
    K030267 EEG MONITOR WITH BIS, MODEL A-2000
    K031694 MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
    K023459 DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
    K020671 PSA4000 EEG MONITOR WITH FRONTAL PSI
    K020218 SNAP EEG MONITOR
    K013389 DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
    K012466 BIS/EEG MODULE
    K011834 BIS ENGINE
    K010965 A-LINE AEP MONITOR
    K011534 EEG MIS MONITOR MODEL # A-2000; BIS ENGINE
    K003038 AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
    K002837 BIS ENGINE
    K001069 MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
    K974496 A-2000 EEG MONITOR WITH BIS
    K973596 SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
    K963644 A-1000 EEG MONITOR AND A-1050 EEG MONITOR

    FEI Numbers

    This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.