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

    BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS

    K Number: K880550 · Decision Jul 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    167

    Basic Information

    Device Name
    BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS
    K Number
    K880550
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1900
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    MEDIMICRO SYSTEMS, INC.
    Date Received
    February 9, 1988
    Decision Date
    July 25, 1988
    Product Code
    BZM
    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
    BZM Calculator, Pulmonary Function Interpretor (Diagnostic)

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