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

    MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER

    K Number: K002409 · Decision Jun 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    325

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    Basic Information

    Device Name
    MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
    K Number
    K002409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Automatic Medical Technologies, Inc.
    Date Received
    August 7, 2000
    Decision Date
    June 28, 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 Automatic Medical Technologies, Inc.

    K Number Device Name
    K023653 MAXONE IV FLUID/BLOOD WARMER, MODEL 102