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

    PLOTTER FOR AS-500

    K Number: K853922 · Decision Nov 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    79
    Applicant Total
    3
    Review Days
    52

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    Basic Information

    Device Name
    PLOTTER FOR AS-500
    K Number
    K853922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1860
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Riko Medical & Scientific Instrument Corp.
    Date Received
    September 23, 1985
    Decision Date
    November 14, 1985
    Product Code
    BZH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZH Meter, Peak Flow, Spirometry

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    Other Clearances by Riko Medical & Scientific Instrument Corp.

    K Number Device Name
    K862023 SPIROMATE AS-600
    K842372 SPIROMATE AS-500