BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    LOW FLUID ALARM

    K Number: K080704 · Decision Apr 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    38
    Applicant Total
    3
    Review Days
    36

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    Basic Information

    Device Name
    LOW FLUID ALARM
    K Number
    K080704
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.2420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Em-Tec GmbH
    Date Received
    March 12, 2008
    Decision Date
    April 17, 2008
    Product Code
    FLN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    FLN Monitor, Electric For Gravity Flow Infusion Systems

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