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

    HYGIENA-TRACH

    K Number: K911080 · Decision May 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    2
    Review Days
    70

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    Basic Information

    Device Name
    HYGIENA-TRACH
    K Number
    K911080
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Apdyne Medical Co.
    Date Received
    March 11, 1991
    Decision Date
    May 20, 1991
    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 Apdyne Medical Co.

    K Number Device Name
    K894369 APDYNE PHENOL APPLICATOR KIT