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510(k) Data Aggregation

    K Number
    K042109
    Device Name
    DIASYS INTEGRA II
    Manufacturer
    NOVACOR FRANCE
    Date Cleared
    2005-03-09

    (216 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVACOR FRANCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diasys Integra II is a non-invasive Ambulatory Blood Pressure (ABP) recorder. It measures the systolic, diastolic, mean blood pressure (BP) and the heart rate (HR). It measures and records the patient position and the arterial rigidity (QKd) at the time of each BP measurement. The BP measurements can be performed using the oscillometric mode, the auscultatory mode or the ECG-gated auscultatory mode. The procedure can be: - transfert to a computer for further analysis and report printing using the DiasySoft . software - printed out directly in a report form by a printer connected to the unit . - transfert to a remote computer through a modem connected to the unit .
    Device Description
    The DIASYS INTEGRA II is a non invasive automatic ambulatory blood pressure recorder. It has two I he DITC I o it it it & erating, the auscultatory mode and the oscillometric mode. The required mode is selected with the DiasySoft Software. If neither of these modes has been specially programmed, the Scienced with the Discount of the most appropriate mode for the patient, according to its own criteria : this is the Automatic mode. The DIASYS INTEGRA II weighs about 195 gr. and contains the electronic system and pneumatic inflation/deflation module. The measurements are saved and can be printed out directly in report form by a printer connected to the unit. If a computer is used, recording conditions and criteria can be set and the a printer of the procedure can be selected, organized, stored and printed out in a fully customised report. The system is only for measurement, recording and display. It makes no diagnoses.
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    K Number
    K042108
    Device Name
    VISTA PLUS
    Manufacturer
    NOVACOR
    Date Cleared
    2005-01-19

    (168 days)

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

    NOVACOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Recorder : Vista Plus is intended to record one, two or three channels surface ECG data from ambulatory patients (Holter) for period up to 11 days on one channel, 6 days on two channels, 4 days on three channels. Recorded data are intended to be analysed by holterSoft Ultima analysis on the ECG data. Software : HolterSoft Ultima is intended to read data acquired by the Vista Plus, analyze, edit, review, report and store these data. The system is intended to be used by trained operators under the direct supervision of a licensed Health Care practitioner in a hospital or a clinic environment.
    Device Description
    The VISTA PLUS holter recorder is a miniature ambulatory ECG recorder (ECG holter) which can continuously record one, two or three channels for a period up to several days ( 1 1 days on 1 channel, 6 days on 2 channels, 4 days on 3 channels). The entire ECG is stored on a removable memory (compact falsh card) and can be read directly by HolterSoft Ultima software installed in a computer. The VISTA PLUS has a microphone allowing the recording of voice messages from the physician or the patient (patient diary) during monitoring. This ECG holter recorder does not perform any analysis on the ECG data. The VISTA PLUS recorder weighs about 100gr. including flash card and batteries and is connected to the patient with a single multilead cable connected to the ECG electrodes. The VISTA PLUS is supplied in a case containing a 128 MB compact flash memory card, one standard ECG cable 180cm, two neck protective pouches, one protective pouch for belt, one shoulder strap, two 1,5V AAA batterics, and a CD-Rom which contains multilingual user's manual.
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    K Number
    K040753
    Device Name
    R-TEST EVOLUTION 3
    Manufacturer
    NOVACOR
    Date Cleared
    2004-06-10

    (78 days)

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

    NOVACOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The R-Test Evolution 3 is a miniature ambulatory ECG Event Recorder that is connected to the patient. As the R-Test Evolution (previous model), this version is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording. The registered data could be sent by a modem or by an e-mail application software.
    Device Description
    The R-Test Evolution 3 is a miniature ambulatory ECG Recorder, which is easy to connect to the patient. The most advanced version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate, and is capable of up to eight days ambulatory recording. The system consists of a unit weighing about 40 grams and includes a lightweight cable which can be worn without any discomfort. The R-Test Evolution 3 is connected to the patient by the electrodes and the cable. Cardiac events are memorized by the R-Test Evolution 3 and then transferred for interpretation: either by a decoder, the Decotest to an electrocardiograph (or an ECG monitor), or to a computer, or by a cable directly to a computer. This transfer is generally done at the physician's surgery at the following visit. It can also be transferred by phone or by e-mail, by modem, either from the patient's home, or from the office of a physician working in connection with an interpretation center. The R-Test Evolution 3 can also transmit real time ECG recordings by telephone; and after reading or not read level and the R-Test Evolution 3 can continue recording any further pathological events which may occur on the same patient. Using a computer enables you to: define the conditions and criteria of the recordings to be made by the R-Test Evolution 3, to select, organize and store the patient data and the results of a procedure, and to print them using specific report parameters.
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    K Number
    K993788
    Device Name
    R.TEST EVOLUTION
    Manufacturer
    NOVACOR DIV.
    Date Cleared
    2000-08-04

    (269 days)

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

    NOVACOR DIV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The R-Test Evolution is a miniature ambulatory ECG Event Recorder that is connected to the patient. This version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording.
    Device Description
    The R-Test Evolution is a miniature ambulatory ECG Recorder, which is easy to connect to the patient. The most advanced version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate, and is capable of up to eight days ambulatory recording. The system consists of a unit weighing about 40 grams and includes a lightweight neck cable which can be worn by the patient unobtrusively and without any discomfort. The R. Test Evolution is connected to the patient by a system of electrodes and the neck cable. Cardiac events are memorized by the R. Test evolution and then transferred by a decoder, the Decotest, to an electrocardiograph or a computer for interpretation: - either directly at the physician's surgery at the following visit, - or by being transmitted telephonically by the patient himself. The R. Test Evolution can also transmit real time ECG recordings by telephone. After making a telephonic or direct transfer, the R. Test Evolution can continue recording any further pathological events which may occur. Using a computer enables you to: - define the conditions and criteria of the recordings to be made by the R. Test Evolution, - to select, organize and store the results of a procedure, and to print them using specific report parameters.
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