Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K210086
    Device Name
    Vitals360 Multi-Vitals Mobile Monitor
    Manufacturer
    VoCare, Inc.
    Date Cleared
    2021-05-20

    (127 days)

    Product Code
    MWI, DQA, DSH, DXN, FLL
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    VoCare, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age. This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently. This VITALS360® device is intended for use in a clinical or home environment. This VITALS360® device is a reusable device following thorough cleaning between uses.
    Device Description
    The Vitals360® is a device designed for spot-checking measuring of the patient's physiological parameters. It can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. Additionally, it can record single lead ECG signal. The Vitals360® capabilities include storing, displaying measuring data.
    Ask a Question

    Page 1 of 1