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

    Servo-air Lite Ventilator System

    K Number: K230173 · Decision Jul 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    23
    Applicant Total
    5
    Review Days
    167

    Basic Information

    Device Name
    Servo-air Lite Ventilator System
    K Number
    K230173
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maquet Critical Care AB
    Date Received
    January 20, 2023
    Decision Date
    July 6, 2023
    Product Code
    MNT
    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
    MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

    Similar 510(k) Clearances

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

    HFT750U

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vivo 3

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    F&P Airvo 3 NIV (PT311US)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Nihon Kohden NKV-330 Ventilator System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small

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

    Other Clearances by Maquet Critical Care AB

    K Number Device Name
    K201874 Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
    K191027 Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
    K182862 Servo Guard
    K180098 SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1