BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇭🇷 Croatia

    Comby EEG Caps

    K Number: K211315 · Decision Nov 9, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    1
    Review Days
    193

    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
    Comby EEG Caps
    K Number
    K211315
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pamel D.O.O
    Date Received
    April 30, 2021
    Decision Date
    November 9, 2021
    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