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

    KNOW-RECIRC

    K Number: K953551 · Decision Jun 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    329

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    Basic Information

    Device Name
    KNOW-RECIRC
    K Number
    K953551
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    H&H Control Systems
    Date Received
    July 28, 1995
    Decision Date
    June 21, 1996
    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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