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

    VOFLEX

    K Number: K840239 · Decision Mar 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    106
    Applicant Total
    43
    Review Days
    45

    Basic Information

    Device Name
    VOFLEX
    K Number
    K840239
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
    Date Received
    January 20, 1984
    Decision Date
    March 5, 1984
    Product Code
    BWF
    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
    BWF Spirometer, Therapeutic (Incentive)

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