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

    FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00

    K Number: K864000 · Decision Jan 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    63
    Applicant Total
    11
    Review Days
    94

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    Basic Information

    Device Name
    FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00
    K Number
    K864000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2870
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Fiberoptic Sensor Technlogies, Inc.
    Date Received
    October 14, 1986
    Decision Date
    January 16, 1987
    Product Code
    DXO
    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
    DXO Transducer, Pressure, Catheter Tip

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    Other Clearances by Fiberoptic Sensor Technlogies, Inc.

    K Number Device Name
    K945753 FST FIBEROPTIC PRESSURE CONVERTER
    K950908 FST CATH-UD, CATHETER
    K945495 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
    K930171 FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR
    K922776 FST COUNCIL TIP FOLEY CATHETER
    K922476 URO-PRO 2000
    K926088 FST CATH UD-DUAL DUAL PRESSURE CATHETER
    K913113 FST CATH-UD CATHETER, MODIFICATION
    K913721 FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM
    K905641 FST CATH-UD CATHETER
    Search all 11 clearances from Fiberoptic Sensor Technlogies, Inc. →