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

    DYNEX CO2/2000, CO2 ANALYZER

    K Number: K862543 · Decision Jul 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    57
    Review Days
    12

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    Basic Information

    Device Name
    DYNEX CO2/2000, CO2 ANALYZER
    K Number
    K862543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Analytical Products, Inc.
    Date Received
    July 3, 1986
    Decision Date
    July 15, 1986
    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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