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

    CAPNOSTAT 5

    K Number: K042601 · Decision Nov 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    7
    Review Days
    56

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    Basic Information

    Device Name
    CAPNOSTAT 5
    K Number
    K042601
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respironics Novametrix, Inc.
    Date Received
    September 24, 2004
    Decision Date
    November 19, 2004
    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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