Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K181248
    Device Name
    Comarch e-Care Platform
    Date Cleared
    2018-10-22

    (165 days)

    Product Code
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Comarch Healthcare SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Comarch e-Care Platform is intended to connect with physiological measurement devices (weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, glucometers) intended to use at home and send the measurement results to central server. Comarch e-Care Platform serves as Software as a Medical Device and can be used only with FDA cleared measurement devices. Comarch e-Care Platform displays the collected measurements on the Web application and securely stores them in a database server, where the caregiver can view them, leave comments and contact patient if necessary. Caregivers are able to set thresholds individually for each patient. Measurement results sent to e-Care Platform from connected devices are analyzed and if result is beyond the threshold, caregiver gets the notification. The Comarch e-Care Platform is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. The Comarch e-Care Platform is contraindicated for patients requiring direct - medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
    Device Description
    Comarch e-Care Platform is a software intended for use in remote patient monitoring outside of traditional healthcare settings (e.g. at home). Components of Comarch e-Care Platform are: Comarch SMA application, Comarch e-Care application, application server, database server. Comarch SMA is a software application intended to use by patients. It is designed to collect, display and transmit vital sign measurements captured from commercially available home monitoring devices. The following vital signs are collected: temperature, glucose, noninvasive blood pressure, pulse oximetry, weight and spirometry.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1