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

    EXPRESS AND OASIS CHEST DRAIN

    K Number: K043140 · Decision Dec 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    63
    Review Days
    23

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    Basic Information

    Device Name
    EXPRESS AND OASIS CHEST DRAIN
    K Number
    K043140
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Atrium Medical Corp.
    Date Received
    November 15, 2004
    Decision Date
    December 8, 2004
    Product Code
    CAC
    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
    CAC Apparatus, Autotransfusion

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