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

    RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE

    K Number: K132138 · Decision Apr 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    34
    Applicant Total
    18
    Review Days
    274

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    Basic Information

    Device Name
    RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
    K Number
    K132138
    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
    Rhythmlink International, LLC
    Date Received
    July 11, 2013
    Decision Date
    April 11, 2014
    Product Code
    PDQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PDQ Neurosurgical Nerve Locator

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    K172503 MR Conditional Cup Electrode, MR Conditional Webb Electrode
    K130220 MR CONDITIONAL PRESSON ELECTRODE
    K130287 MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
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    K120342 EMG RECORDING ELECTRODE ASSEMBLY
    K112435 RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
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