O-Two Medical Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 6 (3 Class I)
- 510(k) Clearances
- 8
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0977-2019 | Class I | e600 Automatic Transport Ventilator, Model Number 01EVE600 | February 12, 2019 |
| Z-0978-2019 | Class I | e700 Automatic Transport Ventilator, Model Number 01EVE700 | February 12, 2019 |
| Z-0976-2019 | Class I | e500 Automatic Transport Ventilator, Model Number 01EVE500 | February 12, 2019 |
| Z-2885-2018 | Class II | O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000 | May 14, 2018 |
| Z-2731-2017 | Class II | Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, | September 30, 2015 |
| Z-2705-2017 | Class II | O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG | June 23, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K173205 | Equinox Advantage | August 29, 2018 |
| 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 |