510(k) K921982 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
MATRX HOPE(R) 5 RESUSCITATOR
| Applicant | Matrix Medica, Inc., Orchard Park NY, US |
| Decision | Substantially Equivalent, Oct 28, 1994 |
| Received | Apr 28, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921982
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.