510(k) K924610 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT
| Applicant | Engineered Medical Systems, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 6, 1993 |
| Received | Sep 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924610
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2013 | Carefusion 2200 Inc 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask;
2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask;
3) Adult Manual Resuscitator, 2K8017, V Terminated |
BTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.