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510(k) Data Aggregation

    K Number
    K973613
    Device Name
    CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER
    Manufacturer
    Date Cleared
    1998-04-14

    (204 days)

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

    **FOLEY **& LARDNER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Citizen CH-611B and CH-611C digital wrist sphygmomanometers (blood pressure meters) are intended to be used for the oscillometric measurement of systolic and diastolic blood pressure and pulse. They are intended to be sold over-the-counter and to health care professionals, and not primarily under the order or direction of a physician.
    Device Description
    The Citizen CH-611B and CH-611C digital wrist sphygmomanometers are small handheld noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's left wrist. The units are contained in a hard plastic housing that contains a user interface panel to which an adjustable wrist cuff is attached by rubber tubing. The user interface panel has a power switch, and a liquid crystal display ("LCD") for displaying the systolic and diastolic blood pressure and pulse, and a memory switch. The device measures blood pressure through the use of an automatically-inflating wrist cuff. The cuff automatically deflates during blood pressure measurement. The only difference between the CH-611B and the CH-611C is that the CH-611B has a memory function which is able to display the last measured systolic and diastolic blood pressure readings (but not the pulse) when a memory recall switch is pressed, while the CH-611C is able to display the last seven measured systolic and diastolic blood pressure readings (but not the pulse) as well as an average of the seven.
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