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

    TraumaGuard Intra-abdominal Pressure Sensing System

    K Number: K210570 · Decision Oct 29, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    245

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    Basic Information

    Device Name
    TraumaGuard Intra-abdominal Pressure Sensing System
    K Number
    K210570
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sentinel Medical Technologies, LLC
    Date Received
    February 26, 2021
    Decision Date
    October 29, 2021
    Product Code
    PHU
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PHU Intra-Abdominal Pressure Monitoring Device

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PHU), ordered by most recent decision date.

    BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Sentinel Medical Technologies, LLC

    K Number Device Name
    K240057 TraumaGuard Intra-abdominal Pressure Sensing System