BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COMPRESSED AIR & OXYGEN GEN./DELIVERY SY

    K Number: K803232 · Decision Feb 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    1
    Review Days
    42

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    Basic Information

    Device Name
    COMPRESSED AIR & OXYGEN GEN./DELIVERY SY
    K Number
    K803232
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Dri-Aire, Inc.
    Date Received
    December 22, 1980
    Decision Date
    February 2, 1981
    Product Code
    CAW
    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
    CAW Generator, Oxygen, Portable

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