510(k) K940581 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, May 6, 1994 |
| Received | Feb 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940581
| 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.