BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MMC AMPLIFIER

    K Number: K943673 · Decision Oct 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    92

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    Basic Information

    Device Name
    MMC AMPLIFIER
    K Number
    K943673
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Melville Software , Ltd.
    Date Received
    July 26, 1994
    Decision Date
    October 26, 1994
    Product Code
    GWL
    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
    GWL Amplifier, Physiological Signal

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    Other Clearances by Melville Software , Ltd.

    K Number Device Name
    K934599 SANDMAN