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

    AMPLAID MARK 4 AND MARK 5

    K Number: K781667 · Decision Nov 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    75
    Applicant Total
    8
    Review Days
    39

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    Basic Information

    Device Name
    AMPLAID MARK 4 AND MARK 5
    K Number
    K781667
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1900
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Amplaid USA, Inc.
    Date Received
    September 25, 1978
    Decision Date
    November 3, 1978
    Product Code
    GWJ
    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
    GWJ Stimulator, Auditory, Evoked Response

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    Other Clearances by Amplaid USA, Inc.

    K Number Device Name
    K861014 AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)
    K832510 EVOKED POTENTIALS SYSTEM MK10
    K810482 SOMATOSENSORY STIMULATOR
    K810473 MK6 ERA SYSTEM
    K810481 VISUAL PATTERN REVERSAL GEN. & PHOTIC S.
    K802963 101, 151, 161 PORTABLE AUDIOMETERS
    K802097 SELF-RECORDING ADMITTANCE METER 709