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

    CADWELL DISPOSABLE PROBE HANDLE

    K Number: K123589 · Decision Mar 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    118

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    Basic Information

    Device Name
    CADWELL DISPOSABLE PROBE HANDLE
    K Number
    K123589
    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
    Cadwell
    Date Received
    November 21, 2012
    Decision Date
    March 19, 2013
    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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    Other Clearances by Cadwell

    K Number Device Name
    K140552 CADWELL SPIKE AND SEIZURE DETECTOR