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

    DIALYSATE METER, MODEL D-6

    K Number: K100237 · Decision Apr 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    DIALYSATE METER, MODEL D-6
    K Number
    K100237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Myron L Company
    Date Received
    January 26, 2010
    Decision Date
    April 23, 2010
    Product Code
    FLB
    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
    FLB Meter, Conductivity, Induction, Remote Type

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