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510(k) Data Aggregation

    K Number
    K161712
    Device Name
    Arm automatic blood pressure monitor
    Manufacturer
    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2017-04-05

    (288 days)

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

    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm~44cm (8.7in~17.3in)) is wrapped around the single upper arm.
    Device Description
    Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.
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    K Number
    K151258
    Device Name
    Arm automatic blood pressure monitor
    Manufacturer
    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2016-02-18

    (282 days)

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

    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is a device intended to measure the systolic, diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm.
    Device Description
    Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff uses the air pump to inflate, and then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic, diastolic blood pressure and pulse rate.
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    K Number
    K151810
    Device Name
    Bpump Blood Pressure Cuff
    Manufacturer
    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2015-12-17

    (168 days)

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

    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bpump Blood Pressure Cuff, Model: BC1000, BC8000, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to complete the measurement of blood parameters on adults.
    Device Description
    The proposed device, Bpump Blood Pressure Cuff, is a rectangle soft inelastic sleeve reusable with a bladder. There is a single-tube connected to the bladder and the Non Invasive Blood Pressure Monitor for inflating and deflating. The device should be connected to a Non Invasive Blood Pressure Monitor to complete the function. There are two sizes for different arm range as follows: Model | Arm range ---|--- BC1000 | 22cm~36cm (8.7in~14.2in) BC8000 | 32cm~44cm (12.6in~17.3in)
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    K Number
    K141416
    Device Name
    BLOOD PRESSURE MONITOR
    Manufacturer
    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2014-10-09

    (133 days)

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

    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for measuring adult blood pressure and pulse rate with circumference ranging from 135 mm to 215 mm.
    Device Description
    Blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.
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    K Number
    K131210
    Device Name
    ELECTRONIC THERMOMETER
    Manufacturer
    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2014-03-18

    (323 days)

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

    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for use in measuring temperature in the human body (Armpit or Oral).
    Device Description
    The body temperature is converted into electronic signal by the temperature sensor, and then the electronic signal is converted into LCD digital display. The Electronic Thermometers TF3100, TF3101 and TF3102 have the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.
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    K Number
    K130325
    Device Name
    ARM AUTOMATIC BLOOD PRESSURE MONITOR
    Manufacturer
    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2013-12-24

    (319 days)

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

    SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for measuring adult blood pressure and pulse rate.
    Device Description
    Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate. The arm automatic blood pressure monitor BF1112, BF1112, BF1113 and BF1115 have the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.
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