BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OXYGEN MOUTHGUARD

    K Number: K944049 · Decision Oct 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    54

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    Basic Information

    Device Name
    OXYGEN MOUTHGUARD
    K Number
    K944049
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Endovations, Inc.
    Date Received
    August 18, 1994
    Decision Date
    October 11, 1994
    Product Code
    MNK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MNK Endoscopic Bite Block

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