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510(k) K063404

SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 by Maquet Critical Care AB — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2007
Date Received
November 9, 2006
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

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  • 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)

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