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

    CARDIAC TRIGGER MONITOR

    K Number: K110987 · Decision Jul 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    27
    Review Days
    105

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    Basic Information

    Device Name
    CARDIAC TRIGGER MONITOR
    K Number
    K110987
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ivy Biomedical Systems, Inc.
    Date Received
    April 8, 2011
    Decision Date
    July 22, 2011
    Product Code
    DRT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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