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510(k) Data Aggregation

    K Number
    K223509
    Device Name
    Compremium Compartment Compressibility Monitoring System (CPM#1)
    Manufacturer
    Compremium AG
    Date Cleared
    2023-04-14

    (143 days)

    Product Code
    LXC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Compremium AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compartmental Compressibility Monitoring System (CPM#1) is intended for real-time and intermittent monitoring of relative compartment compressibility. The relative compartment compressibility (CP Value) is not meant for trend analysis.
    Device Description
    The Compartmental Compressibility Monitoring System (CPM#1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility. The device combines a linear ultrasound array with an integrated pressure sensor into a single handheld probe (CP Probe) to obtain cross-section ultrasound views of the compartment of interest. The device provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure. Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.
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