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

    PROFESSIONAL MARK I BIOFEEDBACK SYS

    K Number: K823381 · Decision Jan 5, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    2
    Review Days
    54

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    Basic Information

    Device Name
    PROFESSIONAL MARK I BIOFEEDBACK SYS
    K Number
    K823381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Srs Co.
    Date Received
    November 12, 1982
    Decision Date
    January 5, 1983
    Product Code
    HCC
    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
    HCC Device, Biofeedback

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