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

    THE PFT FILTER

    K Number: K083233 · Decision Mar 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    226
    Applicant Total
    1
    Review Days
    119

    Basic Information

    Device Name
    THE PFT FILTER
    K Number
    K083233
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PULMONARY FILTRATION TECHNOLOGIES LLC
    Date Received
    November 3, 2008
    Decision Date
    March 2, 2009
    Product Code
    BZG
    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
    BZG Spirometer, Diagnostic

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