510(k) K884068 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
PULMANEX TM (NEO-NATAL SIZE)
| Applicant | Life Design Systems, Inc., Franklin WI, US |
| Decision | Substantially Equivalent, Nov 16, 1988 |
| Received | Aug 30, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884068
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.