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

    CARDIO-PAK LAPAROTOMY PACK

    K Number: K923233 · Decision Mar 20, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    262

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    Basic Information

    Device Name
    CARDIO-PAK LAPAROTOMY PACK
    K Number
    K923233
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Cardio-Med-Associates, Inc.
    Date Received
    July 1, 1992
    Decision Date
    March 20, 1993
    Product Code
    FZH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FZH Apparatus, Air Handling, Room

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    Other Clearances by Cardio-Med-Associates, Inc.

    K Number Device Name
    K923231 CARDIO-PAK BASIC PUMP PACK