BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR

    K Number: K955018 · Decision Jan 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    48
    Applicant Total
    20
    Review Days
    89

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    Basic Information

    Device Name
    TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR
    K Number
    K955018
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Instrumentarium Corp.
    Date Received
    November 2, 1995
    Decision Date
    January 30, 1996
    Product Code
    FFT
    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
    FFT Electrode, Ph, Stomach

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