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

    RX02 EMERGENCY MEDICAL OXYGEN

    K Number: K895956 · Decision Apr 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    114
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    176

    Basic Information

    Device Name
    RX02 EMERGENCY MEDICAL OXYGEN
    K Number
    K895956
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    PROGRESSIVE MEDICAL APPLICATIONS CORP.
    Date Received
    October 11, 1989
    Decision Date
    April 5, 1990
    Product Code
    CAN
    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
    CAN Regulator, Pressure, Gas Cylinder

    Similar 510(k) Clearances

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

    MR Conditional CGA 870

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PORTABLE OXYGEN UNIT SCA900

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    REMCORE REMOTE CONTROLLED OXYGEN REGULATOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    CYL-FIL OXYGEN SYSTEM

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    OXYGEN REGULATOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    VANGUARD SERIES GAS REGULATORS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all