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510(k) Data Aggregation

    K Number
    K061161
    Device Name
    BLOOD PRESSURE METER, MODEL CH-311B
    Date Cleared
    2006-06-26

    (61 days)

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

    CITIZEN WATCH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Model CH-311B Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and are intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
    Device Description
    Not Found
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    K Number
    K052046
    Device Name
    BLOOD PRESSURE METER, MODEL CH-432
    Date Cleared
    2005-10-19

    (82 days)

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

    CITIZEN WATCH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Model CH-432 Blood Pressure Meter intended use is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse are intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
    Device Description
    Not Found
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    K Number
    K001244
    Device Name
    BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
    Date Cleared
    2000-09-26

    (161 days)

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

    CITIZEN WATCH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K984223
    Device Name
    BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471
    Date Cleared
    1999-04-28

    (154 days)

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

    CITIZEN WATCH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Citizen CH-491, CH-481 and CH-471 digital arm sphygmomanometers (blood pressure meters) are intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and 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-491, CH-481 and CH-471 digital arm sphygmomanometers are noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's upper arm. The units are contained in a hard plastic housing that contains a user interface panel, microprocessor and air pump and is connected by tubing to an adjustable arm cuff. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD"). The user interface panel for the CH-481 has an additional switch to control the memory function, while the user interface panel for the CH-491 has additional switches to control the clock and memory functions. The device measures blood pressure through the use of an automatically-inflating arm cuff. The cuff automatically deflates during blood pressure measurement. Model CH-471 has a memory function that displays the last blood pressure readout when the system is turned on. Model CH-481 has a memory function that allows the user to retain seven (7) prior blood pressure measurements. Model CH-491 has a memory function that allows the user to retain thirty (30) prior blood pressure measurements and also includes an LCD display that shows blood pressure measurement in a graph format.
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    K Number
    K973061
    Device Name
    CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B)
    Date Cleared
    1998-03-13

    (207 days)

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

    CITIZEN WATCH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Citizen CH-601A and CH-601B digital wrist sphygmomanometers are intended to be used for the oscillometric measurement of systolic blood pressure and pulse. They are intended to be sold over-the-counter.
    Device Description
    The Citizen Ch-601A and CH-601B 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 and an adjustable wrist cuff. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD") for displaying the systolic and diastolic blood pressure and pulse. 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-601A and the CH-601B is that the CH-601B has a memory function which displays the last blood pressure readout (but not the last pulse) when the system is turned on.
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    K Number
    K954547
    Device Name
    CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER
    Date Cleared
    1997-04-01

    (550 days)

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

    CITIZEN WATCH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Citizen CH-502A and CH-502B finger sphygmomanometers are intended to be used for the oscillometric measurement of systolic and diastolic blood pressure and pulse.
    Device Description
    The Citizen CH-502A and CH-502B finger sphygmomanometers are small hand-held noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's index finger. The units are contained in a hard plastic housing that contains a user interface panel and a finger cuff size adjuster slide. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD") for displaying the systolic and diastolic blood pressure and pulse.
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