510(k) K954194 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
DISPOSABLE HME/FILTER
| Applicant | Engstrom Medical, Sturgis MI, US |
| Decision | Substantially Equivalent, Oct 20, 1995 |
| Received | Sep 6, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954194
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.