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

    ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER

    K Number: K121775 · Decision Nov 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    163

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    Basic Information

    Device Name
    ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
    K Number
    K121775
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vital Signs, Inc., A GE Healthcare Company
    Date Received
    June 18, 2012
    Decision Date
    November 28, 2012
    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 Vital Signs, Inc., A GE Healthcare Company

    K Number Device Name
    K130867 ENFLOW IV FLUID WARMER INSULATED STRAP