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Found 4 results

510(k) Data Aggregation

    K Number
    K102303
    Device Name
    BLOOD PRESSURE METER, MODEL CH-658
    Date Cleared
    2010-09-10

    (25 days)

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

    CITIZEN SYSTEMS JAPAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Citizen Model CH-658 blood pressure meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. The device is intended 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
    K100055
    Device Name
    BLOOD PRESSURE METER, MODEL CH-609
    Date Cleared
    2010-08-30

    (234 days)

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

    CITIZEN SYSTEMS JAPAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Model CH-609 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is 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
    Model CH-609 Blood Pressure Meter
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    K Number
    K093931
    Device Name
    BLOOD PRESSURE METER, MODEL CH-4532
    Date Cleared
    2010-06-10

    (170 days)

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

    CITIZEN SYSTEMS JAPAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Model CH-4532 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is 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
    K100553
    Device Name
    BLOOD PRESSURE METER MODEL CH-101
    Date Cleared
    2010-05-25

    (88 days)

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

    CITIZEN SYSTEMS JAPAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Model CH-101 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is 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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