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510(k) Data Aggregation

    K Number
    K233823
    Device Name
    Ultrasonic Fetal Doppler
    Manufacturer
    Shenzhen Jamr Technology Co., Ltd.
    Date Cleared
    2024-06-28

    (210 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Jamr Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultrasonic Fetal Doppler (Model M520, M521, M523) is intended to detect and display fetal heart rate, and used by health care professionals in a hospital, clinic, community, and home setting for singleton pregnancies after 16 weeks gestation.
    Device Description
    Not Found
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    K Number
    K233146
    Device Name
    Blood Pressure Monitor
    Manufacturer
    Shenzhen Jamr Technology Co., Ltd.
    Date Cleared
    2024-03-19

    (174 days)

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

    Shenzhen Jamr Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the of adult by using the arm cuff (22-42cm), it can be used in medical facilities or at home. It is supplied for OTC use.
    Device Description
    Not Found
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    K Number
    K230409
    Device Name
    Wrist Type Blood Pressure Monitor (W05,W1101L)
    Manufacturer
    Shenzhen Jamr Technology Co., Ltd.
    Date Cleared
    2023-08-25

    (191 days)

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

    Shenzhen Jamr Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult by using the wrist circumference 12.5-21.5cm, it can be used in medical facilities or at home. It is supplied for OTC use.
    Device Description
    The subject device, Wrist Type Blood Pressure Monitor, is a battery driven automatic noninvasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of adults at wrist within its claimed range and accuracy via the oscillometric technique. The device has data storage function for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The subject device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use. The proposed blood pressure monitor includes two models, which are W05, W1101L. All models contain the same software, measurement principle and NIBP algorithm. The main differences are product appearance, specification of pump and specification of the battery. W05 is alkaline battery driven device and W1101L is lithium battery driven device.
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    K Number
    K200437
    Device Name
    Blood Pressure Monitor
    Manufacturer
    Shenzhen Jamr Technology Co., Ltd.
    Date Cleared
    2020-06-25

    (122 days)

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

    Shenzhen Jamr Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7" - 15.7"). Not suitable for neonatal and infants.
    Device Description
    The blood pressure monitor model C02 and F01 are sphygmomanometers with electronic manometer intended to be used for the indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults during inflation. The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LED panel. The monitors C02 and F01 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance.
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