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

    SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE

    K Number: K931963 · Decision Sep 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    48
    Applicant Total
    16
    Review Days
    525

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    Basic Information

    Device Name
    SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE
    K Number
    K931963
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sandhill Scientific, Inc.
    Date Received
    April 21, 1993
    Decision Date
    September 28, 1994
    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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