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510(k) Data Aggregation

    K Number
    K200716
    Device Name
    Electronic Blood Pressure Monitor
    Manufacturer
    Shenzhen Pango Electronic Co., Ltd.
    Date Cleared
    2020-12-04

    (261 days)

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

    Shenzhen Pango Electronic Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm~32 cm and 32 cm~42 cm.
    Device Description
    The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the World Health Organization (WHO) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed electronic blood pressure monitor has six models, including PG-800B18, PG-800B19, PG-800B19L. PG-800B28. PG-800B29. PG-800B51. All models follow the same software, measurement principle and NIBP algorithm. The proposed device is intended to be used in medical facilities or at home. The product is provided non-sterile, and not to be sterilized by the user prior to use.
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    K Number
    K170151
    Device Name
    Electronic Blood Pressure Monitor
    Manufacturer
    Shenzhen Pango Electronic Co., Ltd.
    Date Cleared
    2017-10-13

    (269 days)

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

    Shenzhen Pango Electronic Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm~32 cm and 32 cm~42 cm.
    Device Description
    The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed electronic blood pressure monitor has 12 models, including PG-800B22, PG-800B23, PG-800B26, PG-800B27, PG-800B31, PG-800B32, PG-800B33, PG-800B35, PG-800B36, PG-800B37, PG-800B42 and PG-800B43. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers. The proposed device is intended to be used in medical facilities or at home. The product is provided non-sterile, and not to be sterilized by the user prior to use.
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