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

    DATEX-OHMEDA OXY-AFR SENSOR

    K Number: K042891 · Decision Jun 29, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    26
    Applicant Total
    40
    Review Days
    253

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    Basic Information

    Device Name
    DATEX-OHMEDA OXY-AFR SENSOR
    K Number
    K042891
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex-Ohmeda
    Date Received
    October 19, 2004
    Decision Date
    June 29, 2005
    Product Code
    NLF
    Advisory Committee
    Cardiovascular
    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
    NLF Oximeter, Reprocessed

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