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510(k) Data Aggregation

    K Number
    K062397
    Device Name
    SENTINEL
    Manufacturer
    DEL MAR REYNOLDS MEDICAL, LTD.
    Date Cleared
    2007-01-25

    (162 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEL MAR REYNOLDS MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical Monitoring products and also to act as a "control panel" for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.
    Device Description
    Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Reynolds Monitoring program finended to organize and manage the databases tor compatible Reynolds Monitoring products and also to act as a "control panel" for thes that formerly was used with these devices has been transferred to sections of Sentinel. The program itself can be >plied with all products. The individual products are all data-gathering devices used to collect cardiology patient data (ECG or blood pressure). These devices were previously sold with dedicated software programs that allow the devices to be set-up or configured both to program the devices, and to receive downloaded data from the devices and produce reports. In general, the dedicated programs also have a database uniquely for data from that device. As noted before, these dedicated data bases are replaced by the Sentinel database. Sentinel maintains a common cardiology database for the data collected by the compatible devices, and also permits the user to operate the various devices in a manner identical to the way they were operated as individual products. As a common data base, Sentinel stores data collected from each patient in the section of the database, dedicated to that patient. When used as a method for operating the device, the user selects the iron associated with the device. The user then sees the opening screen for the operation of that device, even all socceeding screens, as they were seen when the device was used with its dedicated program. Sentinel has no capacity for analyzing electrocardiograms. When Sentinel is used with the Pathfinder Holter Analysis program, the Pathfinder program is loaded into the same computer, and Pathfinder cannove alled by Sentinel, but there are no other control links Sentinel can be used on a personal computer (PC) that meets specifications established by Del Mar Reynolds Medical. Sentinel will work with products already owned by the user, or with new products (included in the list of compatible products) that the user may purchase later. Sentinel will work on a single computer, but it has been re-configured to be also used in a network
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    K Number
    K062469
    Device Name
    VOYAGER 12
    Manufacturer
    DEL MAR REYNOLDS MEDICAL, LTD.
    Date Cleared
    2006-11-03

    (71 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEL MAR REYNOLDS MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of Voyager 12 is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram and a rhythm electrocardiogram.
    Device Description
    Voyager 12 is a 12-lead digital electrocardiograph with interpretation of the electrocardiogram. Voyager 12 is a portable, self-contained unit with an internal printer. It permits either manual or automatic interpretation of electrocardiograms.
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    K Number
    K051960
    Device Name
    CARDIONAVIGATOR +
    Manufacturer
    DEL MAR REYNOLDS MEDICAL, LTD.
    Date Cleared
    2005-08-19

    (31 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEL MAR REYNOLDS MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CardioNavigator Plus, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical monitoring products and also to act as a "control panel" for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.
    Device Description
    CardioNavigator Plus, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds monitoring products and also to act as a "control panel" for these products. The software that formerly was used with these devices has been transferred to sections of CardioNavigator Plus. The program itself is supplied with all products. The individual products are all data-gathering devices used to collect cardiology patient data (ECG or blood pressure). These devices were previously sold with dedicated software programs that allow the devices to be set-up or configured both to program the devices, and to receive downloaded data from the devices and produce reports. In general, the dedicated programs also have a database uniquely for data from that device. As noted before, these dedicated databases are replaced by the Cardio Navigator Plus database. CardioNavigator Plus maintains a common cardiology database for the data collected by the compatible devices, and also permits the user to operate the various devices in a manner identical to the way they were operated as individual products. As a common database, CardioNavigator Plus stores data collected from each patient in the section of the database dedicated to that patient. When used as a method for operating the device, the user selects the icon associated with the device. The user then sees the opening screen for the operation of that device, and all succeeding screens, as they were seen when the device was used with its dedicated program. CardioNavigator Plus has no capacity for analyzing electrocardiograms. When CardioNavigator Plus is uses with the Pathfinder Holter analysis program, the Pathfinder program is loaded into the same computer, and CardioNavigator can call Pathfinder, but there are no other links. CardioNavigator Plus can be used on a personal computer (PC) that meets specifications established by Del Mar Reynolds Medical. CardioNavigator Plus will work with products already owned by the user, or with new products (included in the list of compatible products) that the user may purchase later. CardioNavigator Plus will work on a single computer, but it has also been reconfigured to use as a server-workstation system (where the server and the workstation are still personal computers). If a single CardioNavigator Plus will still work on a single computer, but it has been re-configured to use a server-workstation system (where the server and the workstation are still personal computers). If a single computer is used, the server and workstation are combined in that computer
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    K Number
    K040313
    Device Name
    HRV TOOLS
    Manufacturer
    DEL MAR REYNOLDS MEDICAL, LTD.
    Date Cleared
    2004-04-06

    (57 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEL MAR REYNOLDS MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HRV Tools is indicated when it is desired to analyze the basic rhythms of the R-R intervals in electrocardiograms. It only provides numerical analyses of the input electrocardiogram - the program does not make diagnoses
    Device Description
    HRV Tools is a software product (supplied on a CD) that analyzes the basic rhythms of the RR intervals in electrocardiograms, both in the time domain (analysis of time intervals) and in the frequency domain (spectral analysis).
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