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510(k) K191027

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System by Maquet Critical Care AB — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2020
Date Received
April 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type

Other clearances by Maquet Critical Care AB

  • K230173 — Servo-air Lite Ventilator System (July 6, 2023)
  • K201874 — Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventila (April 20, 2021)
  • 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 BSZ

  • K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related (July 11, 2025)
  • K230931 — Atlan (July 23, 2023)
  • K213867 — Carestation 750/750c (March 28, 2023)
  • K201957 — A8, A9 Anesthesia System (March 26, 2021)
  • K171311 — A5 Anesthesia System (January 12, 2018)
  • K171292 — A7 Anesthesia System (January 12, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K160665 — FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia Sy (March 29, 2017)
  • K151570 — Carestation 620/650/650C (January 21, 2016)