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510(k) Data Aggregation

    K Number
    K240729
    Device Name
    Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)
    Date Cleared
    2024-06-14

    (88 days)

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

    Shenzhen Pango Medical Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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. The intended arm circumference includes 22 cm~32 cm.
    Device Description
    The proposed device, Electronic Blood Pressure Monitor, is a battery driven non-invasive blood pressure monitor. It can complete the inflation, deflation 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: mmHq 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 13 models, including PG-800B30, PG-800B39, PG-800B45, PG-800B46, PG-800B48, PG-800B48, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers. The product is provided non-sterile, and not to be sterilized by the user prior to use.
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    K Number
    K223291
    Device Name
    Electronic Blood Pressure Monitor
    Date Cleared
    2023-06-14

    (231 days)

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

    Shenzhen Pango Medical Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm. The patient population does not include adolescents aged 12 to <18 years of age. The patient population includes transition adolescent B (18 to < 22 years of age but treated like adult) and adults (at least 22 years of age).
    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 person at wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or Kpa. The proposed electronic blood pressure monitor has eight models, including PG-800A18, PG-800A19, PG-800A28, PG-800A51, PG-800A52, PG-800A11-1, PG-800A36-1 and PG-800A37-1. All models follow the same software, measurement principle, algorithm and data storage. The main differences are product appearance. The proposed device is intended to be used in medical facilities or at home.
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    K Number
    K212346
    Device Name
    Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
    Date Cleared
    2022-05-05

    (281 days)

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

    Shenzhen Pango Medical Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PG-IRT1612 & PG-IRT1618 Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. The device can be used on people of all ages at home or in hospital environment. PG-IRT1613 & PG-IRT1615 Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead. The device can be used on people of all ages at home or in hospital environment.
    Device Description
    The proposed device includes 4 models, which are PG-IRT1613, PG-IRT1613, PG-IRT1615 and PG-IRT1618. All models of infrared thermometers are intended for people of all age. The proposed devices, Infrared Forehead Thermometers, Model PG-IRT1612 and PG-IRT1618, are hand-held, reusable, battery powered device, which are intended to measure human body temperature by measuring forehead. They are non-contact infrared thermometers. The distance of the measurement is 3~5cm. The proposed devices, Infrared Ear/Forehead Thermometers, Model PG-IRT1613 and PG-IRT1615, are hand-held, reusable, battery powered device, which are intended to measure human body temperature by measuring ear canal or forehead. The ear cavity mode is contact measurement. The forehead mode is non-contact measurement and the measurement distance is 1~5mm. The proposed devices are operated in adjusted mode. The body site used to reference the adjusted temperature value displayed on the proposed device of each model is oral. Principle of operation The proposed device uses a temperature sensor, which can detect the object temperature (OBJ) [human body temperature], environment temperature (NTC) and temperature of sensor itself (AMB); these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module (signal conversion module) in MCU (Microcontroller Unit) of the proposed device. MCU will calculate the body temperature based on OBJ, NTC and AMB, and then transfer to screen for display.
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