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

    KOO AMERICAS VALVE PEEP, MODEL KM-809

    K Number: K050918 · Decision Jun 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    72
    Same Product Code
    79
    Applicant Total
    1
    Review Days
    55

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    Basic Information

    Device Name
    KOO AMERICAS VALVE PEEP, MODEL KM-809
    K Number
    K050918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5965
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Koo Americas, Inc.
    Date Received
    April 12, 2005
    Decision Date
    June 6, 2005
    Product Code
    BYE
    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
    BYE Attachment, Breathing, Positive End Expiratory Pressure

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