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

    NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P

    K Number: K083456 · Decision Mar 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    166
    Review Days
    101

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    Basic Information

    Device Name
    NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
    K Number
    K083456
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nihon Kohden America, Inc.
    Date Received
    November 21, 2008
    Decision Date
    March 2, 2009
    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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