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510(k) Data Aggregation

    K Number
    K102792
    Device Name
    DISPOSABLE BLOOD PRESSURE CUF
    Date Cleared
    2011-01-26

    (121 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREMATE MEDICAL DEVICE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K090014
    Device Name
    CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE
    Date Cleared
    2009-04-09

    (97 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREMATE MEDICAL DEVICE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Caremate Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure by detecting Korotkoff sound. This product is only for adult use.
    Device Description
    The proposed device, Caremate Sphygmomanometer with Stethoscope, is a non-invasive and non automated device intended to measure the blood pressure. It contains of a cuff with inflatable bladder and an aneroid manometer to measure the pressure, as well as a stethoscope for detecting the Korotkoff sound; In addition, an end valve, an air release valve and a bulb are included to complete its function. Caremate Sphygmomanometer with Stethoscope has two models, CM-BPM and CM-PBPM. They are following the same design principle and same components. The only differences are that the bulb and the aneroid manometer are connected together. The operator can held them in one hand. This design feature facilitates the using of this device and will not affect the performance. This product is provided non-sterile and only for adult use.
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