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

    TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470

    K Number: K051587 · Decision Oct 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    8
    Review Days
    132

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    Basic Information

    Device Name
    TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
    K Number
    K051587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tracoe Medical GmbH
    Date Received
    June 15, 2005
    Decision Date
    October 25, 2005
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by Tracoe Medical GmbH

    K Number Device Name
    K203362 TRACOE vario
    K172720 TRACOE silcosoft Tracheostomy Tube
    K152778 TRACOE Cuff Pressure Monitor
    K152865 TRACOE smart Cuff Manager
    K043160 TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
    K961449 TRACHEOSTOMY TUBES TRACOE-FLEX
    K781729 TRACHEOTOMY TUBES