510(k) K141595 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
O-TWO E700,O-TWO E600,O-TWO E500
| Applicant | O-Two Medical Technologies, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Mar 16, 2015 |
| Received | Jun 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141595
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2019 | O-Two Medical Technologies, Inc. e500 Automatic Transport Ventilator, Model Number 01EVE500 Terminated |
BTL | None listed |
| Apr 4, 2019 | O-Two Medical Technologies, Inc. e600 Automatic Transport Ventilator, Model Number 01EVE600 Terminated |
BTL | None listed |
| Apr 4, 2019 | O-Two Medical Technologies, Inc. e700 Automatic Transport Ventilator, Model Number 01EVE700 Terminated |
BTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.