BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Medical Monofilament Sensory Screening Toool

    K Number: K143068 · Decision Jan 14, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    82

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Medical Monofilament Sensory Screening Toool
    K Number
    K143068
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1500
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Monofilament Manufacturing
    Date Received
    October 24, 2014
    Decision Date
    January 14, 2015
    Product Code
    GXB
    Advisory Committee
    Neurology
    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
    GXB Esthesiometer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GXB), ordered by most recent decision date.

    NU-PREP GEL

    FDA 510(k)
    FDA Class 1 ·Neurology

    NEUROTIPS(TM)

    FDA 510(k)
    FDA Class 1 ·Neurology

    ALGESIOMETER

    FDA 510(k)
    FDA Class 1 ·Neurology

    AESTHESIOMETER

    FDA 510(k)
    FDA Class 1 ·Neurology

    TEMP-TESTER

    FDA 510(k)
    FDA Class 1 ·Neurology

    AESTHESIOMETER

    FDA 510(k)
    FDA Class 1 ·Neurology
    View all