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510(k) Data Aggregation

    K Number
    K001317
    Device Name
    ARIA
    Manufacturer
    DEL MAR MEDICAL SYSTEMS, LLC.
    Date Cleared
    2000-07-21

    (86 days)

    Product Code
    MWJ
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEL MAR MEDICAL SYSTEMS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993620
    Device Name
    IMPRESARIO
    Manufacturer
    DEL MAR MEDICAL SYSTEMS, LLC.
    Date Cleared
    1999-11-12

    (17 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEL MAR MEDICAL SYSTEMS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Impresario™ software is intended for the analysis, summary and reporting of prerecorded ambulatory ECG data. At the requirement of a clinician, ambulatory ECG data is recorded in analog or digital form for up to 48 hours in multiple channels. The resultant recordings are segregated into a series of reports presenting significant clinical events as defined by the system, and affirmed by the review and confirmation of a clinician. The system is employed as a screening tool to record ECG events and to present these events to a qualified clinician review, edit and assessment.
    Device Description
    Impresario is an arrhythmia analysis software system that allows the customer to purchase software only and install it on his/her computer. It is compatible with all Del Mar ambulatory ECG (Holter) recorders. It provides 3-channel automated arrhythmia analysis with operator intervention and edit. Reports include summary, totals, trends, histograms, and full disclosure.
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