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

    7100 SWALLOWING WORKSTATION

    K Number: K954798 · Decision Jun 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    30
    Applicant Total
    5
    Review Days
    230

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    Basic Information

    Device Name
    7100 SWALLOWING WORKSTATION
    K Number
    K954798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kay Elemetrics Corp.
    Date Received
    October 18, 1995
    Decision Date
    June 4, 1996
    Product Code
    KLA
    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
    KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube

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