BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    The Luco Hybrid OSA Appliance

    K Number: K160477 · Decision Jul 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    161

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    Basic Information

    Device Name
    The Luco Hybrid OSA Appliance
    K Number
    K160477
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Luco Hybrid Osa Appliance, Inc.
    Date Received
    February 19, 2016
    Decision Date
    July 29, 2016
    Product Code
    OCO
    Advisory Committee
    Unknown
    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
    OCO Mouthguard, Migraine/Tension Headache

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    Other Clearances by Luco Hybrid Osa Appliance, Inc.

    K Number Device Name
    K130797 LUCO HYBRID OSA APPLIANCE