BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    COLIBRI

    K Number: K940041 · Decision Jul 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    16
    Review Days
    204

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    Basic Information

    Device Name
    COLIBRI
    K Number
    K940041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Icor AB
    Date Received
    January 4, 1994
    Decision Date
    July 27, 1994
    Product Code
    BTR
    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
    BTR Tube, Tracheal (W/Wo Connector)

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    Other Clearances by Icor AB

    K Number Device Name
    K954402 ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)
    K953507 TYPE 1 & 2 (HUMIDAIR I & II)
    K952325 ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)
    K952823 FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE
    K941987 HEAT AND MOISTURE EXCHANGERS AND FILTERS
    K941436 AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF
    K925622 FHB, FHB-T, FHBFLEX, FHBFLEX-T
    K914416 BREATH-EASY, MODIFICATION
    K904338 ICOR HCH 4, ICOR HCH 7
    K900150 HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE
    Search all 16 clearances from Icor AB →