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

    LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE

    K Number: K853059 · Decision Jan 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    7
    Review Days
    175

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    Basic Information

    Device Name
    LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE
    K Number
    K853059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Tridak Division of Indicon, Inc.
    Date Received
    July 19, 1985
    Decision Date
    January 10, 1986
    Product Code
    FAP
    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
    FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

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    Other Clearances by Tridak Division of Indicon, Inc.

    K Number Device Name
    K891007 NONIMPLANTED ELECTRICAL CONTINENCE DEVICE
    K860744 OPTHALMIC SURGICAL INSTRUMENTS
    K852856 LABORIE URODYNAMICS PROCESSOR
    K851934 CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA
    K842609 R.L. MEDICAL TWIN LIGHT SOURCE
    K840605 LABORIE FIBREOPTIC LIGHT CABLE