510(k) K934310 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Dec 14, 1993 |
| Received | Sep 1, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934310
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2010 | Westmed Inc BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathi Terminated |
BTM | None listed |
| Sep 8, 2010 | Westmed Inc BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathi Terminated |
BTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.