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

    ULTRAMAX III, DIALYZER REPROCESSING DEVICE

    K Number: K860026 · Decision Mar 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    ULTRAMAX III, DIALYZER REPROCESSING DEVICE
    K Number
    K860026
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medicorp, Inc.
    Date Received
    January 3, 1986
    Decision Date
    March 14, 1986
    Product Code
    LIF
    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
    LIF Dialyzer Reprocessing System

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    Other Clearances by Medicorp, Inc.

    K Number Device Name
    K844850 MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT
    K832705 ULTRAMAX
    K791164 NEGATOVE PRESSURE CONVERTOR
    K791396 MEDI-TRAK PORTABLE TRACTION DEVICE