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510(k) Data Aggregation

    K Number
    K131272
    Device Name
    SIREN EPCR SUITE
    Date Cleared
    2014-01-03

    (245 days)

    Product Code
    Regulation Number
    870.2450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDUSA MEDICAL TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Siren ePCR Suite™ is intended for the collection, storage and printing of patient data that is entered by a user (paramedic), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). Siren ePCR Suite™ is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. Siren ePCR Suite™ is indicated for use by health care providers whenever there is a need for generation of a patient record.
    Device Description
    Siren ePCR Suite™ is a software-only product. Siren ePCR Suite™ is a medical data collection system used to collect, store and print patient data that is entered by a user (caregiver), or captured from specified medical devices, and is integrated into a patient care report (patient electronic medical record). Siren ePCR Suite™ is non-alarming software that runs on a variety of commercial off-the-shelf hardware.
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