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510(k) Data Aggregation

    K Number
    K070826
    Device Name
    KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
    Manufacturer
    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
    Date Cleared
    2007-08-15

    (142 days)

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

    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wrist Measurement Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
    Device Description
    Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Specially, it has the function of blood pressure level classification.
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    K Number
    K070828
    Device Name
    KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
    Manufacturer
    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
    Date Cleared
    2007-08-15

    (142 days)

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

    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual. Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-30cm.
    Device Description
    Fully Automatic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Specially, it has the function of blood pressure level classification.
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    K Number
    K070395
    Device Name
    KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
    Manufacturer
    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
    Date Cleared
    2007-06-07

    (118 days)

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

    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KD-525E Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-30cm.
    Device Description
    KD-525E Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data.
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    K Number
    K052450
    Device Name
    KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
    Manufacturer
    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
    Date Cleared
    2006-02-28

    (174 days)

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

    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KD-788 Wrist Measurement Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
    Device Description
    KD-788 Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist automatically inflated and released by an infernal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can divide into 4 groups and record 30 memory each group with the month, day and time of measuring.
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    K Number
    K052676
    Device Name
    KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
    Manufacturer
    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
    Date Cleared
    2006-02-17

    (143 days)

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

    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KD-322 Semi Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time except infants and unconscious people, with the air cuff around the left upper arm according to instruction in the user's guide manual. The KD-322 Semi Automatic Electronic Blood Pressure Monitor is intended to measure the diastolic and systolic blood pressures and pulse rate of an intended to modules the a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 8.6614 inches to 13.78 inches.
    Device Description
    KD-322 Semi Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this device is used to monitor systolic, diastolic blood pressure and pulse rate which will be displayed on a LCD with an electronic interface. After wrapping the air cuff around the left upper arm 1-2cm above elbow joint, automatically inflated or inflated by an internal pump, the device can analyze the signals promptly and display the results.
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    K Number
    K051847
    Device Name
    KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
    Manufacturer
    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
    Date Cleared
    2006-01-05

    (182 days)

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

    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KD-768 Wrist Measurement Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
    Device Description
    KD-768 Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 120 times measuring result with the month, day and time of measuring.
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    K Number
    K042418
    Device Name
    KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
    Manufacturer
    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
    Date Cleared
    2005-03-21

    (199 days)

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

    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KD-575 Memory Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive, technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 8.6614 inches to 13.78 inches
    Device Description
    KD-575 Fuily Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results. It can storage and show 120 times measuring result with the month, day, time of measuring.
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    K Number
    K030359
    Device Name
    KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
    Manufacturer
    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
    Date Cleared
    2003-11-06

    (276 days)

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

    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KD-726 Memory Wrist Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
    Device Description
    KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data.
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    K Number
    K030358
    Device Name
    KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
    Manufacturer
    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
    Date Cleared
    2003-10-31

    (270 days)

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

    KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KD-622 Fully Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 8.6614 inches to 13.78 inches.
    Device Description
    KD-622 Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data.
    Ask a Question

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