BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇵🇱 Poland

    Comarch e-Care Platform

    K Number: K181248 · Decision Oct 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    1
    Review Days
    165

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    Basic Information

    Device Name
    Comarch e-Care Platform
    K Number
    K181248
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Comarch Healthcare SA
    Date Received
    May 10, 2018
    Decision Date
    October 22, 2018
    Product Code
    DRG
    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
    DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

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