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

    Dosis SAM

    K Number: K180410 · Decision Jan 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    336

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    Basic Information

    Device Name
    Dosis SAM
    K Number
    K180410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dosis, Inc.
    Date Received
    February 14, 2018
    Decision Date
    January 16, 2019
    Product Code
    MQS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQS System, Hemodialysis, Access Recirculation Monitoring

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