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

    MODEL 405T WITH ETCO2 OPTION

    K Number: K964961 · Decision May 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    301
    Applicant Total
    20
    Review Days
    154

    Basic Information

    Device Name
    MODEL 405T WITH ETCO2 OPTION
    K Number
    K964961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    IVY BIOMEDICAL SYSTEMS, INC.
    Date Received
    December 11, 1996
    Decision Date
    May 14, 1997
    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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