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

    FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE

    K Number: K950044 · Decision Sep 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    301
    Applicant Total
    66
    Review Days
    253

    Basic Information

    Device Name
    FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE
    K Number
    K950044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FUKUDA DENSHI USA, INC.
    Date Received
    January 5, 1995
    Decision Date
    September 15, 1995
    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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