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

    PERCUTANEOUS TRACHEOSTOMY TUBE KIT

    K Number: K931611 · Decision Aug 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    1
    Review Days
    148

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    Basic Information

    Device Name
    PERCUTANEOUS TRACHEOSTOMY TUBE KIT
    K Number
    K931611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Crandall Medical Devices
    Date Received
    April 1, 1993
    Decision Date
    August 27, 1993
    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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