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

    INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE

    K Number: K040188 · Decision Apr 14, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    0
    Applicant Total
    48
    Review Days
    77

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    Basic Information

    Device Name
    INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE
    K Number
    K040188
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeger Medical Systems, Inc.
    Date Received
    January 28, 2004
    Decision Date
    April 14, 2004
    Product Code
    NHP
    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
    NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)

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