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510(k) K243917

F&P Optiflow Air/Oxygen Flow Source by Fisher &Paykel Healthcare , Ltd. — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2025
Date Received
December 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type

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  • K223684 — F&P 820 Humidification System (September 5, 2023)

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  • K222794 — FlowStar Touch Digital Mixer Flowmeter (July 28, 2023)
  • K221494 — Quality Mix Blender, Oxymixer (January 23, 2023)
  • K202480 — Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (April 22, 2021)
  • K173205 — Equinox Advantage (August 29, 2018)
  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • K142291 — GMX Series Medical Air/Oxygen Blender (May 19, 2015)
  • K113687 — EQUINOX RELIEVE (April 30, 2012)