BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    eCareManager 4.0.1

    K Number: K153156 · Decision Sep 30, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    113
    Applicant Total
    4
    Review Days
    333

    Basic Information

    Device Name
    eCareManager 4.0.1
    K Number
    K153156
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VISICU, INC.
    Date Received
    November 2, 2015
    Decision Date
    September 30, 2016
    Product Code
    MSX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MSX System, Network And Communication, Physiological Monitors

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    Other Clearances by VISICU, INC.

    K Number Device Name
    K141706 ECARE COORDINATOR (ECC)
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    K001972 ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK