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

    RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM

    K Number: K011238 · Decision Jan 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    260

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    Basic Information

    Device Name
    RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
    K Number
    K011238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Metracor Technologies, Inc.
    Date Received
    April 23, 2001
    Decision Date
    January 8, 2002
    Product Code
    LZF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LZF Pump, Infusion, Analytical Sampling

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