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

    XDCS-100

    K Number: K932083 · Decision Dec 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    5
    Review Days
    230

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    Basic Information

    Device Name
    XDCS-100
    K Number
    K932083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microwave Medical Systems, Inc.
    Date Received
    April 30, 1993
    Decision Date
    December 16, 1993
    Product Code
    DXT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Microwave Medical Systems, Inc.

    K Number Device Name
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    K914867 QWIK-1(TM) IN-LINE IV FLUID WARMER
    K913110 PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED
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