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

    SPEACELABS MULTIGAS MODULE

    K Number: K112173 · Decision Oct 5, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    4
    Applicant Total
    10
    Review Days
    69

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    Basic Information

    Device Name
    SPEACELABS MULTIGAS MODULE
    K Number
    K112173
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spacelabs Healthcare
    Date Received
    July 28, 2011
    Decision Date
    October 5, 2011
    Product Code
    CBR
    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
    CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

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