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510(k) Data Aggregation

    K Number
    K041789
    Device Name
    NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T
    Manufacturer
    Date Cleared
    2004-07-15

    (13 days)

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

    MEDITEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Measuring Systolic and Diastolic blood pressure and pulse rates in adult patients with arm circumferences between 5½~ 7½ inches using the oscillometric method
    Device Description
    MD-880B, MD-900T models are oscillometric systems intended for measurement of blood pressure and purse rate in a home care environment. - 1)MD-880B : MD-880B employs the oscillometric method for measurement of blood pressure and heart rate. A cuff is wrapped around the wrist and inflates to a pressure sufficient to initially interrupt blood flow. As cuff pressure is gradually reduced, a sensor inside the cuff detects the small oscillations in pressure against the cuff produced by expansion and contractions of the arteries in the wrist in response to each heart beat. The amplitude of these pressure waves is measured to monitor changes in the character of blood flow and the corresponding cuff pressure at which these changes occur is detected. The systolic and diastolic pressure in millimeters of mercury, followed by the heart rate in beats per minute, is displayed as a numerical value on the LCD. The cuff is automatically inflated by a built-in air pump(low noise) and selected inflation level by checking heart beat signal. The inflation is automatically activated in about 1 second after power on. The three-row, 9-digit LCD displays systolic pressure(upper 3digits) and diastolic pressure(middle 3 digits) and heart rate(lower 3-digits). In addition, the date and time are displayed(8-digit). MD-880B incorporates a constant air release valve to regulate deflation rate, within limits of 2 or 3 mmHg/sec to optimize measurement accuracy. The pressure measurement range is 20 to 285 mmHq. And keys are consisting of push-button switch instead of touch screen(MD-900T) for low cost model. MD-880B is powered by two AAA-size batteries and are equipped with a circuit that will automatically cut off power after about 1 minutes of non-use to conserve battery charge. - 2) MD-900T : MD-900T employs the oscillometric method for measurement of blood pressure and heart rate. A cuff is wrapped around the wrist and inflates to a pressure sufficient to initially interrupt blood flow. As cuff pressure is gradually reduced, a sensor inside the cuff detects the small oscillations in pressure against the cuff produced by expansion and contractions of the arteries in the wrist in response to each heart beat. The amplitude of these pressure waves is measured to monitor changes in the character of blood flow and the corresponding cuff pressure at which these changes occur is detected. The systolic and diastolic pressure in millimeters of mercury, followed by the heart rate in beats per minute, is displayed as a numerical value on the LCD. The cuff is automatically inflated by a built-in air pump(low noise) and selected inflation level by checking heart beat signal. The inflation is automatically activated in about 1 second after power on. The three-row, 9-digit LCD displays systolic pressure(upper 3-digits) and diastolic pressure(middle 3 digits) and heart rate(lower 3-digits). In addition, the date and time are displayed(8-digit). MD-900T incorporates a constant air release valve to regulate deflation rate, within limits of 2 or 3 mmHg/sec to optimize measurement accuracy. The pressure measurement range is 20 to 285 mmHg. MD-900T is powered by two AAA-size batteries and are equipped with a circuit that will automatically cut off power after about 1 minutes of non-use to conserve battery charge.
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    K Number
    K002655
    Device Name
    DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550
    Manufacturer
    Date Cleared
    2000-09-06

    (12 days)

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

    MEDITEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K992328
    Device Name
    FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800
    Manufacturer
    Date Cleared
    1999-07-21

    (9 days)

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

    MEDITEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Noninvasive measurement of systolic and diastolic blood pressure and heart rate in adult patients, i.e., age 18 and above, in a home care environment.
    Device Description
    Three Meditec models are oscillometric systems intended for measurement of blood pressure and heart rate in a home care environment. Three models has a built-in pump for automatic inflation. Three Models include a constant air regulate deflation rate, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure and heart rate, and a memory function. Three models utilize a pressure measurement algorithm designed to detect, process, and store pressure readings. The pressure measurement range is 20 to 285 mmHg maintained within limits of 2 of 3 mmHg/sec to optimize measurement accuracy. Three models are powered by four AA-size batteries and are equipped with a circuit that will automatically cut off power after about 3 minutes of non-use to conserve battery charge.
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    K Number
    K990380
    Device Name
    (1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700
    Manufacturer
    Date Cleared
    1999-02-22

    (14 days)

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

    MEDITEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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