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

    RELAXATION COURSE MODEL 1000

    K Number: K770787 · Decision Jun 17, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    2
    Review Days
    46

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    Basic Information

    Device Name
    RELAXATION COURSE MODEL 1000
    K Number
    K770787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Cybernetic Medical, Inc.
    Date Received
    May 2, 1977
    Decision Date
    June 17, 1977
    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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