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

    LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)

    K Number: K953559 · Decision May 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    2
    Review Days
    331

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    Basic Information

    Device Name
    LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
    K Number
    K953559
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Seidel Medizin GmbH
    Date Received
    June 20, 1995
    Decision Date
    May 16, 1996
    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 Seidel Medizin GmbH

    K Number Device Name
    K872486 LARKEL DEVICE W/ATTACHMENTS A-H