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

    ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076

    K Number: K994330 · Decision Jan 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    25
    Review Days
    26

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
    K Number
    K994330
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aspect Medical Systems, Inc.
    Date Received
    December 23, 1999
    Decision Date
    January 18, 2000
    Product Code
    GXY
    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
    GXY Electrode, Cutaneous

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GXY), ordered by most recent decision date.

    BioWave BioWraps

    FDA 510(k)
    FDA Class 2 ·Neurology

    Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MR Conditional Cup Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    Tutamen Self Adhesive Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ceribell Brain Monitor Headband

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    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. →