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510(k) Data Aggregation

    K Number
    K090027
    Device Name
    BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107
    Manufacturer
    ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
    Date Cleared
    2009-02-02

    (28 days)

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

    ZEN STRONG MEDICAL TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZSBP-003/004/005/006/007/008 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the patient of the age over 18 years old. ZSBP-102/103/104/105/106/107 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age over 18 years old. All measurement values can be read out and keep memory on the LCD panel for home care use.
    Device Description
    Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at wrist or upper arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software... and so on. The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at wrist or upper arm is inflated to the estimated pressure level, then deflated to zero automatically. During the inflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base: - Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method) - Heart beat rate.
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    K Number
    K070578
    Device Name
    CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER
    Manufacturer
    ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
    Date Cleared
    2007-07-11

    (132 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZEN STRONG MEDICAL TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The clinical thermometer / model ZSDT-XXX digital thermometer measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal processor and digital LCD (display) unit. The device is reusable and intended for oral, rectal, or armpit temperature measurement for home use on people at all ages. The clinical thermometer / model ZSET-XXX infrared thermometer are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The device is a reusable and intended for home use on people at all ages.
    Device Description
    A> ZSDT-XXX Digital thermometer. The digital clinical thermometer, models ZSDT-XXX Series, are the electronic thermometers by using a themistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, measuring circuit for the measurement of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 1.5V/DC AG3 or SG3 Alkaline battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically. and displays 'Low battery' in LCD display. Regarding the performance of ZSDT-XXX, it was designed and verified according to the US standard ASTM E 1112-00. B> ZSET-XXX Infrared thermometer. The infrared thermometer, models ZSET-XXX, are the handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared. This system uses a 3.0 V DC battery(2xAAA batteries) for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of ZSET-XXX, they were designed and verified according to the US standard ASTM E 1965-2002.
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    K Number
    K070473
    Device Name
    BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX
    Manufacturer
    ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
    Date Cleared
    2007-05-23

    (92 days)

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

    ZEN STRONG MEDICAL TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZSBP-001 and ZSBP-002 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the patient of the age over 18 years old. ZSBP-101 series of blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age over 18 years old. All measurement values can be read out and keep memory on the LCD panel for home care use.
    Device Description
    Basically two different type of blood pressure monitors are to be included in this 510(K) submission, the wrist type and upper arm type. The main intended use for these two tvpe of blood pressure monitor is as the following description: 1> ZSBP-001 and ZSBP-002 blood pressure monitor. This series of device measures automatically the human being systolic, diastolic blood pressure and heart beat rate from wrist by using the oscillometric method for the patient of ages above 18 years old. 2> ZSBP-101 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age above 18 tears old. For all of these three blood pressure monitors, the measurement values can be read out and keep memory on the LCD panel for home care use( without the involvement of professional physician). From the construction point of view, the non-invasive electronic blood pressure monitor was composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at upper arm or wrist, pneumatic pumping inflation and deflation system, housing, display LCD, and measuring software, and memories ....... etc. The main operation for the non-invasive electronic blood pressure monitor is carried out in such a way that the measuring cuff at wrist or upper arm is inflated to the set pressure level, then deflated to zero automatically. During the inflation and deflation, the pressure change with respective to time were recorded as the database of measurement. Then the following measuring results will be calculated against the measurement database, and displayed on the LCD of device: Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method) Heart beat rate. In addition to the main blood pressure and heart beat rate measuring function, the ZSBP series of blood pressure monitor provides also the memory function for user to store the result of measurement.
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