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510(k) Data Aggregation

    K Number
    K151781
    Device Name
    Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
    Date Cleared
    2016-05-27

    (331 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVY BIOMEDICAL SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ivy Biomedical Model 7810 ("7810") is a basic cardiac monitor used to provide cardiac and respiratory trigger pulse outputs used by third-party systems that require ECG or respiratory synchronization. Cardiac and respiratory synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization. The 7810 is intended for use in pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals. The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality.
    Device Description
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