BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare

    K Number: K151377 · Decision Jul 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    1
    Review Days
    55

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    Basic Information

    Device Name
    ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare
    K Number
    K151377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Compression System (Dbn) , Ltd.
    Date Received
    May 22, 2015
    Decision Date
    July 16, 2015
    Product Code
    JOW
    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
    JOW Sleeve, Limb, Compressible

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