BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    CARNATION OXYGEN

    K Number: K850626 · Decision Mar 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    21

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    Basic Information

    Device Name
    CARNATION OXYGEN
    K Number
    K850626
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5580
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Cathay Consolidated, Inc.
    Date Received
    February 19, 1985
    Decision Date
    March 12, 1985
    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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