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

    Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

    K Number: K190353 · Decision Apr 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    420

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    Basic Information

    Device Name
    Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
    K Number
    K190353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Residential Home Sleep Services
    Date Received
    February 15, 2019
    Decision Date
    April 10, 2020
    Product Code
    PLC
    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
    PLC Sleep Appliances With Patient Monitoring

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