BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    AIR ENTRAINER 900RT008

    K Number: K953711 · Decision Nov 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    54
    Applicant Total
    17
    Review Days
    91

    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
    AIR ENTRAINER 900RT008
    K Number
    K953711
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5330
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fisher & Paykel Electronics , Ltd.
    Date Received
    August 9, 1995
    Decision Date
    November 8, 1995
    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

    Other Clearances by Fisher & Paykel Electronics , Ltd.

    K Number Device Name
    K973161 CPAP HUMIDIFIER (HC 200)
    K972885 SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970
    K971695 SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
    K971461 SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
    K970432 INFANT RADIANT WARMER - MODELS IW910 AND IW920
    K953392 HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
    K953949 HUMIDIFIER & ACCESSORIES
    K934140 MR290 HUMIDIFICATION CHAMBER SINGLE USE
    K924234 CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272
    K915460 HEATED RESPIRATORY HUMIDIFIER HC100
    Search all 17 clearances from Fisher & Paykel Electronics , Ltd. →