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

    RESPIFIT S, MODEL RS-LR1001004

    K Number: K080299 · Decision Jan 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    107
    Applicant Total
    1
    Review Days
    343

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    Basic Information

    Device Name
    RESPIFIT S, MODEL RS-LR1001004
    K Number
    K080299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eumedics Medizintechnik Und Marketing GmbH
    Date Received
    February 5, 2008
    Decision Date
    January 13, 2009
    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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