Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K172965
    Device Name
    Handheld VitalSigns Monitoring System
    Date Cleared
    2018-12-17

    (447 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Visiomed Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BW-X07HD Handheld VitalSigns Monitoring System is intended to be used in hospital, clinic, homecare, home and other medical settings where patient care is offered by qualified healthcare personnel who can use the device to monitor the patient's physical indexes, including ECG, SpO2, NIBP and TEMP as well as the pulse rate. For measuring ECG, SpO2 the intended patient population is adult, for measuring NIBP the intended patient population is both adult and pediatric aged more than 3 years old, whereas for measuring TEMP the intent population is all types of people including newborn, pediatric and adult. The device is used to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional.
    Device Description
    The BW-X07HD Handheld VitalSigns Monitoring System is a handheld, smart and wireless connected medical device. The device can be easily used by healthcare professional personnel, ordinary users or patients, to monitor multiple physiological indexes, including TEMP, ECG, NIBP and SpO2 as well as the pulse rate. Medical data can be stored locally and can be sent through WiFi, 3G or 4G network. The device incorporates an embedded system and an Android application. The embedded system integrates the Temp module, the ECG, NIBP, SpO2 module and the wireless module together. The device allows users to communicate through an HD video conferencing system but cannot be used as phone (only IP connection, Micro SIM card for data transmission).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1