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

    TRACOE smart Cuff Manager

    K Number: K152865 · Decision Sep 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    38
    Applicant Total
    8
    Review Days
    363

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    Basic Information

    Device Name
    TRACOE smart Cuff Manager
    K Number
    K152865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5750
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tracoe Medical GmbH
    Date Received
    September 30, 2015
    Decision Date
    September 27, 2016
    Product Code
    BSK
    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
    BSK Cuff, Tracheal Tube, Inflatable

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    Other Clearances by Tracoe Medical GmbH

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    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