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

    CATHETER, THERMAL DILUTION FIBEROPTIC

    K Number: K781134 · Decision Aug 17, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    18
    Applicant Total
    12
    Review Days
    42

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    Basic Information

    Device Name
    CATHETER, THERMAL DILUTION FIBEROPTIC
    K Number
    K781134
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Oximetrix, Inc.
    Date Received
    July 6, 1978
    Decision Date
    August 17, 1978
    Product Code
    DQE
    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
    DQE Catheter, Oximeter, Fiber-Optic

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    Other Clearances by Oximetrix, Inc.

    K Number Device Name
    K853018 MODEL 3000 OPTICATH COMPUTER
    K842622 HEMO STATIC/ESU SCALPEL SYSTEM
    K833966 PUMP INFUSION WEARABLE INFUSION PUMP
    K823007 OPTICATH HEPARIN COATED, FLOW-DIRECT
    K821056 FLOW DIRECTED THERMAL-DILUTION CATHETER
    K821057 FLOW DIRECTED THERMAL-DILUTION INFUSION
    K820674 OPTICATH
    K811391 OXIMETRIX ACCU SAT CPB
    K791868 OXIMETRIX SHAW HEMOSTATIC SURG. SYS.
    K781879 HEATER, OXIMETER SYSTEM
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