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510(k) Data Aggregation

    K Number
    K120545
    Device Name
    HX-461
    Date Cleared
    2012-10-23

    (243 days)

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

    SEERS TECHNOLOGY CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HX-461 is intended for used by adults to measure the systolic and diastolic blood pressure and pulse rate and transfer medical device data electronically to the designated health care center through internet website. HX-461 enables user reqistration for user-specific data management, and provides blood pressure measurement function. It can receive blood pressure, blood qlucose and body fat measurement values by connecting with respective measurement instruments supporting Bluetooth connection, or by docking a blood glucose meter on its back. In addition, HX-461 supports wired/wireless communication with a designated person including video communication.. It has three size of cuff for blood pressure measurement. User chooses the cuff depending on their arm circumference.
    Device Description
    HX-461 applies the oscillometric method to measure patient blood pressure. It is composed of blood pressure module, cuff, LCD touch pad control panel and CPU processer based on Window CE to operate the blood pressure module. Patient can easily operate the device with the touch pad using the cuff installed in the device. Operator can control by touch screen based on SEERSTECHNOLOGY CO., LTD.'s software. It has unique communication function that can get the medical information from other blood pressure meter, blood glucose meter and body fat measurement device using bluetooth module and wire connector. HX-461 has a wire and wireless internet function.
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