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

    ANIMEC, MODELS AM-2S-4 AND AM-2S-5

    K Number: K012906 · Decision Oct 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    41

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    Basic Information

    Device Name
    ANIMEC, MODELS AM-2S-4 AND AM-2S-5
    K Number
    K012906
    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
    August 29, 2001
    Decision Date
    October 9, 2001
    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
    K024373 MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5