510(k) K892221 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
PULMONARY RESUSCITATOR, MODIFICATION
| Applicant | Life Design Systems, Inc., Franklin WI, US |
| Decision | Substantially Equivalent, May 18, 1989 |
| Received | Mar 30, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892221
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.