510(k) K970991 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
DATEX ENGSTOM MANUAL RESUSCITATOR
| Applicant | Promedic, Inc., Mccordsville IN, US |
| Decision | Unknown, Jun 16, 1997 |
| Received | Mar 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970991
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.