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

    SOMATOSENSORY STIMULATOR

    K Number: K810482 · Decision Apr 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    8
    Review Days
    65

    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
    SOMATOSENSORY STIMULATOR
    K Number
    K810482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Amplaid USA, Inc.
    Date Received
    February 23, 1981
    Decision Date
    April 29, 1981
    Product Code
    GWF
    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
    GWF Stimulator, Electrical, Evoked Response

    Similar 510(k) Clearances

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

    SafeOp 3: Neural Informatix System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Nicolet EDX

    FDA 510(k)
    FDA Class 2 ·Neurology

    Natus Ultrapro S100 (982A0594)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Delphi Stimulator

    FDA 510(k)
    FDA Class 2 ·Neurology

    SafeOp 3: Neural Informatix Systeem

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Amplaid USA, Inc.

    K Number Device Name
    K861014 AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)
    K832510 EVOKED POTENTIALS SYSTEM MK10
    K810473 MK6 ERA SYSTEM
    K810481 VISUAL PATTERN REVERSAL GEN. & PHOTIC S.
    K802963 101, 151, 161 PORTABLE AUDIOMETERS
    K802097 SELF-RECORDING ADMITTANCE METER 709
    K781667 AMPLAID MARK 4 AND MARK 5