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    K Number
    K070086
    Device Name
    SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR
    Manufacturer
    SENSACARE LTD.
    Date Cleared
    2007-05-10

    (121 days)

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

    SENSACARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor is a hand held battery operated arm type blood pressure monitor which is intended for use by adults (age 18 or older) for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) systolic pressure : 30 to 280 mmHg (2) diastolic pressure : 20 to 255 mmHg (3) heart rate : 20 to 255 times/minutes.
    Device Description
    The SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. SAA-102 uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant and The pressure of the cuff is completely released automatically at the end w the measurement. At the same time, the measurements are displayed on the LCD display for one minute. After one minute without operation, SAA-102 turns off automatically. SAA-102 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
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    K Number
    K061935
    Device Name
    SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR
    Manufacturer
    SENSACARE LTD.
    Date Cleared
    2006-11-08

    (121 days)

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

    SENSACARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is a hand held battery operated wrist type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) systolic pressure : 30 to 280 mmHg (2) diastolic pressure : 20 to 255 mmHg (3) heart rate : 20 to 255 times/minutes.
    Device Description
    The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. SAW-102 uses an inflated cuff which is wrapped around the upper wrist. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for one minute. After one minute without operation, SAW-102 turns off automatically. SAW-102 measures blood pressure and pulse rate even when an irregular heartbeat occurs. The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is a hand held battery operated wrist type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) systolic pressure : 30 to 280 mmHg (2) diastolic pressure : 20 to 255 mmHg (3) heart rate : 20 to 255 times/minutes.
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