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

    NEURO-AIDE

    K Number: K942926 · Decision Aug 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    4
    Applicant Total
    7
    Review Days
    42

    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
    NEURO-AIDE
    K Number
    K942926
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1750
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Burke Neutech, Inc.
    Date Received
    June 22, 1994
    Decision Date
    August 3, 1994
    Product Code
    GWY
    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
    GWY Pinwheel

    Similar 510(k) Clearances

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

    BIS SRS (SEMI-RESUABLE SENSOR)

    FDA 510(k)
    FDA Class 1 ·Neurology

    SENSITESTER

    FDA 510(k)
    FDA Class 1 ·Neurology

    1-380 PINWHEEL (WARTENBERG)

    FDA 510(k)
    FDA Class 1 ·Neurology

    PINWHEEL

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

    Other Clearances by Burke Neutech, Inc.

    K Number Device Name
    K955326 SPORTS CONTRAST THERAPY SYSTEM ST 7000
    K952117 EPILATOR
    K943497 CONTRAST 7000 THERAPY SYSTEM
    K945803 THERMAFLEX, MODEL SD 55 C.P.M.H.
    K940160 TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
    K926151 LSI6000 THERMAL THERAPY SYSTEM