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510(k) Data Aggregation

    K Number
    K093981
    Device Name
    YRNSORTIP OXIMANOMETER
    Manufacturer
    Date Cleared
    2010-07-22

    (210 days)

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

    Cnoga Medical LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TensorTip - Non-invasive Hemodynamic blood pressure monitor trending device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.
    Device Description
    The TensorTip - Non-invasive Hemodynamic Blood Pressure Monitor measurement chamber is designed to measure spot-check of heartbeat and blood pressure trending levels by simply inserting the finger into the device "chamber". It contains a dedicated finger compartment having soft gel on the upper compartment lead door suiting the finger to be placed inside. The device incorporates LEDs (Light Emitting Diode); a sensor array enables to sense the spectrum from near UV to near IR and a rechargeable battery for power supply. The device has large display for displaying temporal Pulse Per Minute (PPM) and Systolic and Diastolic Blood Pressure trending. In addition it shows the capillary blood waveform and the blood pressure variation during the measurement period. It is utilizing software that collects and presents the measured data.
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