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

    Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1

    K Number: K201874 · Decision Apr 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    19
    Review Days
    287

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    Basic Information

    Device Name
    Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
    K Number
    K201874
    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
    July 7, 2020
    Decision Date
    April 20, 2021
    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

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    Other Clearances by Maquet Critical Care AB

    K Number Device Name
    K230173 Servo-air Lite Ventilator System
    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
    K160665 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
    K153688 Edi Catheter ENFit
    K151814 SERVO-U Ventilator System, SERVO-n Ventilator System
    K153461 Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
    K123149 SERVO-I VENTILATOR SYSTEM
    K133958 FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
    Search all 19 clearances from Maquet Critical Care AB →