BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5

    K Number: K024373 · Decision Jan 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
    K Number
    K024373
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elltec Co., Ltd.
    Date Received
    December 31, 2002
    Decision Date
    January 28, 2003
    Product Code
    LGZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LGZ Warmer, Thermal, Infusion Fluid

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    Other Clearances by Elltec Co., Ltd.

    K Number Device Name
    K012906 ANIMEC, MODELS AM-2S-4 AND AM-2S-5