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510(k) K113687

EQUINOX RELIEVE by O-Two Medical Technologies, Inc. — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2012
Date Received
December 15, 2011
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.

  • K173205 — Equinox Advantage (August 29, 2018)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • 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)
  • K173205 — Equinox Advantage (August 29, 2018)
  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • K142291 — GMX Series Medical Air/Oxygen Blender (May 19, 2015)