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

    DMR/CO2 COMBO KTI

    K Number: K960468 · Decision Apr 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    42
    Review Days
    85

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    Basic Information

    Device Name
    DMR/CO2 COMBO KTI
    K Number
    K960468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Nellcor Puritan Bennett, Inc.
    Date Received
    February 1, 1996
    Decision Date
    April 26, 1996
    Product Code
    BTM
    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
    BTM Ventilator, Emergency, Manual (Resuscitator)

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