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

    OXYGEN SENSING DEVICE, MODIFICATION

    K Number: K913392 · Decision Jul 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    120
    Applicant Total
    29
    Review Days
    354

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    Basic Information

    Device Name
    OXYGEN SENSING DEVICE, MODIFICATION
    K Number
    K913392
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Devilbiss Health Care, Inc.
    Date Received
    July 29, 1991
    Decision Date
    July 17, 1992
    Product Code
    CCL
    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
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase

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