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

    NERVE LOCATOR/MONITOR SYSTEM MODIFICATION

    K Number: K954601 · Decision Dec 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    5
    Review Days
    101

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    Basic Information

    Device Name
    NERVE LOCATOR/MONITOR SYSTEM MODIFICATION
    K Number
    K954601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rln Systems, Inc.
    Date Received
    September 12, 1995
    Decision Date
    December 22, 1995
    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
    K003745 LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
    K925008 RLN NERVE LOCATOR/MONITOR; MODEL A
    K912508 NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION
    K895676 HEMOSTAT/STIMULATOR PROBE