BZR — Mixer, Breathing Gases, Anesthesia Inhalation Class II
FDA Device Classification
Classification Details
- Product Code
- BZR
- Device Class
- Class II
- Regulation Number
- 868.5330
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K243917 | fisher and paykel healthcare | F&P Optiflow Air/Oxygen Flow Source | July 14, 2025 |
| K241465 | parker hannifin corporation | Midas Flowmeter; eAVS | September 19, 2024 |
| K231895 | maxtec | Maxtec MaxBlend2+p | December 4, 2023 |
| K230987 | baldus sedation gmbh and co. kg | FlowStar Analog Mixer Flowmeter | September 14, 2023 |
| K222794 | baldus sedation gmbh and co. kg | FlowStar Touch Digital Mixer Flowmeter | July 28, 2023 |
| K221494 | dehas medical systems | Quality Mix Blender, Oxymixer | January 23, 2023 |
| K202480 | parker hannifin | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 | April 22, 2021 |
| K173205 | o-two medical technologies | Equinox Advantage | August 29, 2018 |
| K161718 | maxtec | MaxBlend 2, MaxBlend Lite | October 27, 2016 |
| K142291 | gentec (shanghai) corporation | GMX Series Medical Air/Oxygen Blender | May 19, 2015 |
| K113687 | o-two medical technologies | EQUINOX RELIEVE | April 30, 2012 |
| K113232 | maxtec | MAXMIXING BLOCK | March 1, 2012 |
| K101286 | linde healthcare | SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 | October 20, 2011 |
| K103317 | atom medical corporation | RESUSCITATION UNIT 105 | April 20, 2011 |
| K092484 | cardinal health 207 | HELIOX LOW FLOW SENTRY BLENDER | April 2, 2010 |
| K090781 | precision medical | HELIO2 BLENDER | August 13, 2009 |
| K081335 | tenacore holdings | TENACORE OXYGEN BLENDER, MODEL TB-2000 | November 14, 2008 |
| K053232 | precision medical | PRECISION BLENDER | January 10, 2006 |
| K051192 | praxair | PRAXAIR MEDICAL AIR MIXER | September 6, 2005 |
| K050381 | cs medical | CS MEDICAL TTCF GAS DELIVERY SYSTEM | July 13, 2005 |