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

    MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR

    K Number: K884080 · Decision Oct 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    5
    Review Days
    24

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    Basic Information

    Device Name
    MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR
    K Number
    K884080
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Fenem, Inc.
    Date Received
    September 27, 1988
    Decision Date
    October 21, 1988
    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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    Other Clearances by Fenem, Inc.

    K Number Device Name
    K894429 MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR
    K894053 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR
    K883950 MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER
    K883821 FEF(TM) END-TIDAL CO2 DETECTOR