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510(k) Data Aggregation

    K Number
    K161845
    Device Name
    Electronic Blood Pressure Monitor
    Date Cleared
    2017-07-31

    (391 days)

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

    Shenzhen Pango Electronic Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electronic Blood Pressure Monitor is intended to measure the systolic 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 adult 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-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A33, PG-800A36 and PG-800A37. 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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