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

    AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)

    K Number: K861014 · Decision Aug 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    8
    Review Days
    155

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    Basic Information

    Device Name
    AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)
    K Number
    K861014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Amplaid USA, Inc.
    Date Received
    March 18, 1986
    Decision Date
    August 20, 1986
    Product Code
    GWL
    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
    GWL Amplifier, Physiological Signal

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    K802963 101, 151, 161 PORTABLE AUDIOMETERS
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