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510(k) K173205

Equinox Advantage by O-Two Medical Technologies, Inc. — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2018
Date Received
October 2, 2017
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

Other clearances by O-Two Medical Technologies, Inc.

  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K113687 — EQUINOX RELIEVE (April 30, 2012)
  • K112546 — O_TWO CPAP SYSTEM (December 27, 2011)
  • K093862 — CAREVENT HANDHELD CPAP SYSTEM (May 6, 2010)
  • K081330 — CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) (March 6, 2009)
  • K051469 — CAREVENT ATV+ AND CAREVENT MRI (September 28, 2005)
  • K051889 — CAREVENT CA AND DRA (August 30, 2005)

Other clearances for product code BZR

  • K243917 — F&P Optiflow Air/Oxygen Flow Source (July 14, 2025)
  • K241465 — Midas Flowmeter; eAVS (September 19, 2024)
  • K231895 — Maxtec MaxBlend2+p (December 4, 2023)
  • K230987 — FlowStar Analog Mixer Flowmeter (September 14, 2023)
  • 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)
  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • K142291 — GMX Series Medical Air/Oxygen Blender (May 19, 2015)
  • K113687 — EQUINOX RELIEVE (April 30, 2012)