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

    MASK, BI FLO NASAL OXYGEN

    K Number: K781741 · Decision Dec 1, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    54
    Applicant Total
    7
    Review Days
    55

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    Basic Information

    Device Name
    MASK, BI FLO NASAL OXYGEN
    K Number
    K781741
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5580
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Inhal-O-Tech Medical Plastic
    Date Received
    October 7, 1978
    Decision Date
    December 1, 1978
    Product Code
    BYG
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BYG Mask, Oxygen

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    Other Clearances by Inhal-O-Tech Medical Plastic

    K Number Device Name
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    K760329 MASK, DISPOSABLE OXYGEN THERAPY
    K760330 CANNULA, DISPOSABLE OXYGEN TTHERAPY