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

    T-GUARD

    K Number: K945537 · Decision Mar 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    129

    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
    T-GUARD
    K Number
    K945537
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Med ET AL Development
    Date Received
    November 14, 1994
    Decision Date
    March 23, 1995
    Product Code
    LQX
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LQX Device, Finger-Sucking

    Similar 510(k) Clearances

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

    THUMBSHELPER POWER RING

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all