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

    Slow Wave DS8

    K Number: K191320 · Decision Oct 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    506

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    Basic Information

    Device Name
    Slow Wave DS8
    K Number
    K191320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Slow Wave, Inc.
    Date Received
    May 15, 2019
    Decision Date
    October 2, 2020
    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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    Other Clearances by Slow Wave, Inc.

    K Number Device Name
    K240463 Slow Wave DS8 (SWDS802)