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

    PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE

    K Number: K974387 · Decision Sep 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    112
    Applicant Total
    5
    Review Days
    649

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    Basic Information

    Device Name
    PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
    K Number
    K974387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microwave Medical Systems, Inc.
    Date Received
    November 21, 1997
    Decision Date
    September 1, 1999
    Product Code
    KDJ
    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
    KDJ Set, Administration, For Peritoneal Dialysis, Disposable

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    Other Clearances by Microwave Medical Systems, Inc.

    K Number Device Name
    K932083 XDCS-100
    K914867 QWIK-1(TM) IN-LINE IV FLUID WARMER
    K913110 PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED
    K900295 PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES