BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Lunoa System

    K Number: K180608 · Decision Jun 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    Lunoa System
    K Number
    K180608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nightbalance BV
    Date Received
    March 7, 2018
    Decision Date
    June 5, 2018
    Product Code
    MYB
    Advisory Committee
    Dental
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MYB Pillow, Cervical (For Mild Sleep Apnea)

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