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510(k) K201874

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 by Maquet Critical Care AB — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2021
Date Received
July 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Maquet Critical Care AB

  • K230173 — Servo-air Lite Ventilator System (July 6, 2023)
  • K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (March 18, 2020)
  • K182862 — Servo Guard (October 21, 2019)
  • K180098 — SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 (March 19, 2019)
  • K160665 — FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia Sy (March 29, 2017)
  • K153688 — Edi Catheter ENFit (March 2, 2017)
  • K151814 — SERVO-U Ventilator System, SERVO-n Ventilator System (December 21, 2015)
  • K153461 — Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guid (December 11, 2015)
  • K123149 — SERVO-I VENTILATOR SYSTEM (June 20, 2014)
  • K133958 — FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 (March 20, 2014)

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