510(k) K854037 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
PULMANEX
| Applicant | Life Design Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Nov 1, 1985 |
| Received | Sep 11, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854037
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.