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510(k) Data Aggregation
K Number
K993788Device Name
R.TEST EVOLUTION
Manufacturer
NOVACOR DIV.
Date Cleared
2000-08-04
(269 days)
Product Code
MLO
Regulation Number
870.2800Why 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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