BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    AS/3 AIRWAY MODULE

    K Number: K943458 · Decision Feb 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    16
    Applicant Total
    55
    Review Days
    211

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    Basic Information

    Device Name
    AS/3 AIRWAY MODULE
    K Number
    K943458
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1620
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex Division Instrumentarium Corp.
    Date Received
    July 18, 1994
    Decision Date
    February 14, 1995
    Product Code
    CBS
    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
    CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

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