BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NEWPORT VENTILATOR MODEL E100

    K Number: K820746 · Decision Apr 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    22
    Review Days
    28

    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
    NEWPORT VENTILATOR MODEL E100
    K Number
    K820746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Newport Medical Instruments, Inc.
    Date Received
    March 19, 1982
    Decision Date
    April 16, 1982
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

    Similar 510(k) Clearances

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

    Evita (V800); Evita (V600)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Inbentus Versatile

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VPAP Pediatric Face Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vivo 45 LS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SV600, SV800 Ventilator

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

    Other Clearances by Newport Medical Instruments, Inc.

    K Number Device Name
    K121891 NEWPORT AURA VENTILATOR
    K111146 NEWPORT HT70 VENTILATOR
    K101803 NEWPORT E360 VENTILATOR
    K090888 NEWPORT HT70 FAMILY OF VENTILATORS
    K082724 NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
    K061094 NEWPORT E500 WAVE VENTILATOR
    K053502 NEWPORT E360 VENTILATOR
    K041082 NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
    K030780 NEWPORT E500 WAVE VENTILATOR
    K992133 NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL
    Search all 22 clearances from Newport Medical Instruments, Inc. →