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

    MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR

    K Number: K894429 · Decision Sep 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    5
    Review Days
    63

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR
    K Number
    K894429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Fenem, Inc.
    Date Received
    July 17, 1989
    Decision Date
    September 18, 1989
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CCK), ordered by most recent decision date.

    Capnostream™35 Portable Respiratory Monitor (PM35MN)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Medical Gas Analyzer (AG200)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AIM (N/A)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Fenem, Inc.

    K Number Device Name
    K894053 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR
    K884080 MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR
    K883950 MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER
    K883821 FEF(TM) END-TIDAL CO2 DETECTOR