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

    SYRINGE SET, 3-WAY THERMODILUTIN

    K Number: K760402 · Decision Aug 23, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    2
    Review Days
    17

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    Basic Information

    Device Name
    SYRINGE SET, 3-WAY THERMODILUTIN
    K Number
    K760402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Omp Laboratories, Inc.
    Date Received
    August 6, 1976
    Decision Date
    August 23, 1976
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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