BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    TYPE 9292 INTERFACE CAPNOGRAPH

    K Number: K896737 · Decision Feb 28, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    46
    Review Days
    90

    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
    TYPE 9292 INTERFACE CAPNOGRAPH
    K Number
    K896737
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    S & W Medico Teknik
    Date Received
    November 30, 1989
    Decision Date
    February 28, 1990
    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 S & W Medico Teknik

    K Number Device Name
    K940933 9267 SPO2 ATHENA MODULE
    K913013 TCPO2 9260 MODULE - SYSTEM ATHENA
    K915633 MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA
    K930134 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT
    K923418 9293/1 INTERFACE MODULE
    K911611 SYSTEM ATHENA, MODIFICATION
    K922314 VENTILATOR INTERFACE 9291/4
    K912815 NIBP 9225 COMBI
    K912000 TYPE INTERFACE 9271/1 INCUBATOR/WARMER
    K912183 TYPE 9050/NEO
    Search all 46 clearances from S & W Medico Teknik →