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

    AMBU OXYGEN REGULATOR

    K Number: K901623 · Decision Apr 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    112
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    20

    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
    AMBU OXYGEN REGULATOR
    K Number
    K901623
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Flotec, Inc.
    Date Received
    April 6, 1990
    Decision Date
    April 26, 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

    Other Clearances by Flotec, Inc.

    K Number Device Name
    K970371 FLOTEC OXYSAVRR (S)