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

    OXYGEN CONCENTRATOR UCC-100

    K Number: K823582 · Decision Jan 5, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    6
    Review Days
    30

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    OXYGEN CONCENTRATOR UCC-100
    K Number
    K823582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Linde Div. Union Carbide Corp.
    Date Received
    December 6, 1982
    Decision Date
    January 5, 1983
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CAW), ordered by most recent decision date.

    Portable Oxygen Concentrator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oxygen Concentrator (OX-5A, OX-5C)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OxyGo Portable Oxygen Concentrator (1400-7000)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DeVilbiss 5 Liter Oxygen Concentrator (555)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oxygen Concentrator (J10A)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oxygen Concentrator-P2-O5E

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Linde Div. Union Carbide Corp.

    K Number Device Name
    K882208 MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES
    K882209 MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES
    K882210 MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES
    K832143 MARK III OXYGEN WALKER SYS. RESERVOIR
    K821841 MEDIGAS SUCTION/DRAINAGE EQUIPMENT