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

    THE EQUALIZER AIRWAY DEVICE

    K Number: K870501 · Decision Mar 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    28

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    Basic Information

    Device Name
    THE EQUALIZER AIRWAY DEVICE
    K Number
    K870501
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Sleep Renewal, Inc.
    Date Received
    February 4, 1987
    Decision Date
    March 4, 1987
    Product Code
    LQZ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LQZ Device, Jaw Repositioning

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