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

    MODIFICATION TO: SPIRIT

    K Number: K080023 · Decision Jun 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    54
    Applicant Total
    7
    Review Days
    164

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    Basic Information

    Device Name
    MODIFICATION TO: SPIRIT
    K Number
    K080023
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5655
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Caire, Inc.
    Date Received
    January 4, 2008
    Decision Date
    June 16, 2008
    Product Code
    BYJ
    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
    BYJ Unit, Liquid-Oxygen, Portable

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