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510(k) K230173

Servo-air Lite Ventilator System by Maquet Critical Care AB — Product Code MNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2023
Date Received
January 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Maquet Critical Care AB

  • K201874 — Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventila (April 20, 2021)
  • 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)

Other clearances for product code MNT

  • K242931 — HFT750U (May 15, 2025)
  • K240779 — Vivo 3 (December 13, 2024)
  • K233643 — F&P Airvo 3 NIV (PT311US) (August 9, 2024)
  • K213521 — Nihon Kohden NKV-330 Ventilator System (July 1, 2022)
  • K191624 — F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Versio (March 9, 2020)
  • K170367 — Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large (August 24, 2017)
  • K122715 — STELLAR 150 (June 17, 2013)
  • K121623 — BIPAP A 40 VENTILATORY SUPPORT SYSTEM (December 14, 2012)
  • K113640 — STELLAR 150 (April 5, 2012)
  • K102985 — V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS (April 5, 2011)