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

    ACCU02 SYSTEM

    K Number: K051007 · Decision Jun 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    70
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    ACCU02 SYSTEM
    K Number
    K051007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miti Corp.
    Date Received
    April 20, 2005
    Decision Date
    June 16, 2005
    Product Code
    NFB
    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
    NFB Conserver, Oxygen

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