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

    OLYMPUS CRITICAL CARE MONITORING SYSTEM

    K Number: K963935 · Decision Jan 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    14
    Applicant Total
    7
    Review Days
    114

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    Basic Information

    Device Name
    OLYMPUS CRITICAL CARE MONITORING SYSTEM
    K Number
    K963935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optical Sensors, Inc.
    Date Received
    October 1, 1996
    Decision Date
    January 23, 1997
    Product Code
    CCC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

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