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

    SALTER LABS #4001 ORAL NASAL CO2 SAMPLING CANNULA

    K Number: K864199 · Decision Feb 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    48
    Review Days
    106

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    Basic Information

    Device Name
    SALTER LABS #4001 ORAL NASAL CO2 SAMPLING CANNULA
    K Number
    K864199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Salter Labs
    Date Received
    October 27, 1986
    Decision Date
    February 10, 1987
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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