BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04

    K Number: K101286 · Decision Oct 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    531

    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
    SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
    K Number
    K101286
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5330
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Linde Healthcare AB
    Date Received
    May 7, 2010
    Decision Date
    October 20, 2011
    Product Code
    BZR
    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
    BZR Mixer, Breathing Gases, Anesthesia Inhalation

    Similar 510(k) Clearances

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

    F&P Optiflow Air/Oxygen Flow Source

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Midas Flowmeter; eAVS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Maxtec MaxBlend2+p

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FlowStar Analog Mixer Flowmeter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FlowStar Touch Digital Mixer Flowmeter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Quality Mix Blender, Oxymixer

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