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510(k) Data Aggregation

    K Number
    K171029
    Device Name
    eCareCoordinator
    Manufacturer
    Visicu Inc.
    Date Cleared
    2017-07-14

    (99 days)

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

    Visicu Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to engage in use of this software, to transmit medical and non-medical information through integrated technologies.
    Device Description
    eCareCoordinator (eCC) is a software-only telemedicine system, designed to enable the support of patients in the home setting. eCC is intended to support the clinician with monitoring of remote patients. Clinicians use eCC to manage populations of ambulatory care patients, while keeping primary care physicians informed of patient status. eCC is a software-only device and does not contain any patient-contacting components.
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