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

    OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor

    K Number: K181571 · Decision Apr 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    309

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    Basic Information

    Device Name
    OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
    K Number
    K181571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mark Abramson, D.D.S., Inc.
    Date Received
    June 14, 2018
    Decision Date
    April 19, 2019
    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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    Other Clearances by Mark Abramson, D.D.S., Inc.

    K Number Device Name
    K030440 OASYS-ORAL AIRWAY SYSTEM