Company ยท CA
O-Two Medical Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2018. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 29, 2018 | K173205 | Equinox Advantage O-Two Medical Technologies, Inc., CA | BZR |
| Mar 16, 2015 | K141595 | O-TWO E700,O-TWO E600,O-TWO E500 O-Two Medical Technologies, Inc., CA | BTL |
| Apr 30, 2012 | K113687 | EQUINOX RELIEVE O-Two Medical Technologies, Inc., CA | BZR |
| Dec 27, 2011 | K112546 | O_TWO CPAP SYSTEM O-Two Medical Technologies, Inc., CA | BYE |
| May 6, 2010 | K093862 | CAREVENT HANDHELD CPAP SYSTEM O-Two Medical Technologies, Inc., CA | BTL |
| Mar 6, 2009 | K081330 | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) O-Two Medical Technologies, Inc. | BTL |
| Sep 28, 2005 | K051469 | CAREVENT ATV+ AND CAREVENT MRI O-Two Medical Technologies, Inc., CA | BTL |
| Aug 30, 2005 | K051889 | CAREVENT CA AND DRA O-Two Medical Technologies, Inc., CA | BTL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2019 | O-Two Medical Technologies, Inc. e700 Automatic Transport Ventilator, Model Number 01EVE700 Terminated |
BTL | K141595 |
| Apr 4, 2019 | O-Two Medical Technologies, Inc. e600 Automatic Transport Ventilator, Model Number 01EVE600 Terminated |
BTL | K141595 |
| Apr 4, 2019 | O-Two Medical Technologies, Inc. e500 Automatic Transport Ventilator, Model Number 01EVE500 Terminated |
BTL | K141595 |
| May 14, 2018 | O-Two Medical Technologies, Inc. O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System
Model#: 01EQ1000 Terminated |
BZR | K113687 |
| Jun 22, 2017 | O-Two Medical Technologies, Inc. Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 ---
DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products Terminated |
NAE | None listed |
| Jun 22, 2017 | O-Two Medical Technologies, Inc. O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 ---
INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to Terminated |
JBS | None listed |