BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000

    K Number: K031694 · Decision Aug 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    37
    Applicant Total
    25
    Review Days
    88

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    Basic Information

    Device Name
    MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
    K Number
    K031694
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aspect Medical Systems, Inc.
    Date Received
    June 2, 2003
    Decision Date
    August 29, 2003
    Product Code
    OLW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLW Index-Generating Electroencephalograph Software

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    Other Clearances by Aspect Medical Systems, Inc.

    K Number Device Name
    K093183 BIS QUATRO SENSOR
    K091854 BIS CLICK SENSOR/CABLE
    K072286 BIS EEG VISTA MONITOR SYSTEM AND BISX
    K062613 BIS EEG MONITOR VIEW
    K070069 ZIPPREP ELECTRODE
    K062692 BIS BILATERAL SENSOR
    K052981 BIS EEG MONITOR, MODEL BISX4
    K052362 BIS EEG MONITOR, MODEL A-3000
    K050313 BIS SRS (SEMI-RESUABLE SENSOR)
    K041670 BIS PEDIATRIC SENSOR
    Search all 25 clearances from Aspect Medical Systems, Inc. →