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510(k) Data Aggregation

    K Number
    K070825
    Device Name
    LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR
    Date Cleared
    2007-05-25

    (60 days)

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

    LITTLE DOCTOR (SHANGHAI) ELECTRONIC MANUFACTURING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Shanghai Little Doctor LD8 Digital Wrist Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
    Device Description
    The LD8 Digital Wrist Blood Pressure Monitor, Model LD8 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable wrist cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
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    K Number
    K061279
    Device Name
    LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
    Date Cleared
    2006-08-18

    (102 days)

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

    LITTLE DOCTOR (SHANGHAI) ELECTRONIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Shanghai Little Doctor LD-578 Fully Automatic Digital Blood Pressure Monitor, is a device intended to measure the systelic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
    Device Description
    The LD-578 Fully Automatic Digital Blood Pressure Monitor, Model LD-578 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
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