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

    THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE

    K Number: K941938 · Decision Aug 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    5
    Review Days
    106

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    Basic Information

    Device Name
    THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE
    K Number
    K941938
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intercare Diagnostics, Inc.
    Date Received
    April 21, 1994
    Decision Date
    August 5, 1994
    Product Code
    HCC
    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
    HCC Device, Biofeedback

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