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

    PB100 DIAGNOSTIC SPIROMETER

    K Number: K911143 · Decision Nov 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    110
    Review Days
    260

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    Basic Information

    Device Name
    PB100 DIAGNOSTIC SPIROMETER
    K Number
    K911143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1900
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Puritan Bennett Corp.
    Date Received
    March 14, 1991
    Decision Date
    November 29, 1991
    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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