BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    TRACOE vario

    K Number: K203362 · Decision Aug 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    8
    Review Days
    262

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    Basic Information

    Device Name
    TRACOE vario
    K Number
    K203362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tracoe Medical GmbH
    Date Received
    November 16, 2020
    Decision Date
    August 5, 2021
    Product Code
    JOH
    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
    JOH Tube Tracheostomy And Tube Cuff

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    Other Clearances by Tracoe Medical GmbH

    K Number Device Name
    K172720 TRACOE silcosoft Tracheostomy Tube
    K152778 TRACOE Cuff Pressure Monitor
    K152865 TRACOE smart Cuff Manager
    K051587 TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
    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