BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AG-839PA CO2 MODULE AND ACCESSORIES

    K Number: K944027 · Decision Aug 31, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    1
    Applicant Total
    166
    Review Days
    14

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    Basic Information

    Device Name
    AG-839PA CO2 MODULE AND ACCESSORIES
    K Number
    K944027
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2900
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nihon Kohden America, Inc.
    Date Received
    August 17, 1994
    Decision Date
    August 31, 1994
    Product Code
    BXO
    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
    BXO Transducer, Gas Pressure

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