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

    LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET

    K Number: K003745 · Decision Jan 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    5
    Review Days
    43

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    Basic Information

    Device Name
    LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
    K Number
    K003745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rln Systems, Inc.
    Date Received
    December 4, 2000
    Decision Date
    January 16, 2001
    Product Code
    ETN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETN Stimulator, Nerve

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    Other Clearances by Rln Systems, Inc.

    K Number Device Name
    K954601 NERVE LOCATOR/MONITOR SYSTEM MODIFICATION
    K925008 RLN NERVE LOCATOR/MONITOR; MODEL A
    K912508 NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION
    K895676 HEMOSTAT/STIMULATOR PROBE