O-Two Medical Technologies, Inc.
O-Two Medical Technologies, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2018, with 6 FDA device recalls on record.
Top product codes for O-Two Medical Technologies, Inc.
FDA recalls by O-Two Medical Technologies, Inc.
- Z-0977-2019 — e600 Automatic Transport Ventilator, Model Number 01EVE600
- Z-0978-2019 — e700 Automatic Transport Ventilator, Model Number 01EVE700
- Z-0976-2019 — e500 Automatic Transport Ventilator, Model Number 01EVE500
- Z-2885-2018 — O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
- Z-2731-2017 — 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 are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.
- Z-2705-2017 — 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 provide ventilations at a rate appropriate for adult patients
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by O-Two Medical Technologies, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.