BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    2300 SERIES MGO PORTABLE OXYGEN

    K Number: K134023 · Decision Apr 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    1
    Review Days
    116

    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
    2300 SERIES MGO PORTABLE OXYGEN
    K Number
    K134023
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ultra Electronics Limited Precision Air & Land SY
    Date Received
    December 30, 2013
    Decision Date
    April 25, 2014
    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