Equinox Advantage
FDA 510(k) K173205 · O-Two Medical Technologies, Inc.
510(k) numberK173205
Submission
- Device name
- Equinox Advantage
- Applicant
- O-Two Medical Technologies, Inc.
Brampton, CA - Received
- October 2, 2017
- Decision date
- August 29, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZR – Mixer, Breathing Gases, Anesthesia Inhalation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5330
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BZR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243917 | F&P Optiflow Air/Oxygen Flow SourceBZR · Traditional | Fisher & Paykel Healthcare, Ltd. | 07/14/2025SE |
| K241465 | Midas Flowmeter; eAVSBZR · Traditional | Parker Hannifin Corporation | 09/19/2024SE |
| K231895 | Maxtec MaxBlend2+pBZR · Traditional | Maxtec, LLC | 12/04/2023SE |
| K230987 | FlowStar Analog Mixer FlowmeterBZR · Traditional | Baldus Sedation GmbH & Co. KG | 09/14/2023SE |
| K222794 | FlowStar Touch Digital Mixer FlowmeterBZR · Traditional | Baldus Sedation GmbH & Co. KG | 07/28/2023SE |
| K221494 | Quality Mix Blender, OxymixerBZR · Traditional | Dehas Medical Systems GmbH | 01/23/2023SE |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50BZR · Traditional | Parker Hannifin | 04/22/2021SE |
| K161718 | MaxBlend 2, MaxBlend LiteBZR · Traditional | Maxtec, LLC | 10/27/2016SE |
| K142291 | GMX Series Medical Air/Oxygen BlenderBZR · Traditional | Gentec (Shanghai) Corporation | 05/19/2015SE |
| K113687 | Equinox RelieveBZR · Traditional | O-Two Medical Technologies, Inc. | 04/30/2012SE |
More from O-Two Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | 03/16/2015SE |
| K113687 | Equinox RelieveBZR · Traditional | 04/30/2012SE |
| K112546 | O_Two CPAP SystemBYE · Traditional | 12/27/2011SE |
| K093862 | Carevent Handheld CPAP SystemBTL · Traditional | 05/06/2010SE |
| K081330 | Carevent Par (Public Access Resuscitator)BTL · Traditional | 03/06/2009SE |
| K051469 | Carevent Atv+ and Carevent MRIBTL · Traditional | 09/28/2005SE |
| K051889 | Carevent Ca and DraBTL · Special | 08/30/2005SE |
Questions and answers
When was Equinox Advantage cleared by the FDA?
Equinox Advantage (K173205) received a 510(k) decision of Substantially Equivalent on August 29, 2018, 331 days after the submission was received.
What is the product code of K173205?
The FDA product code is BZR – Mixer, Breathing Gases, Anesthesia Inhalation, a Class II (moderate risk) device regulated under 21 CFR 868.5330.