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

    MT ALERT INFUSION MONITOR

    K Number: K013121 · Decision Oct 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    MT ALERT INFUSION MONITOR
    K Number
    K013121
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sierra Biosearch, Inc.
    Date Received
    September 18, 2001
    Decision Date
    October 15, 2001
    Product Code
    FLN
    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
    FLN Monitor, Electric For Gravity Flow Infusion Systems

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