510(k) K972657 ยท CAF Nebulizer (Direct Patient Interface)
ULTRAMIST 2000
| Applicant | Texas Medical Industries, Inc., Royse City TX, US |
| Decision | Substantially Equivalent, Feb 2, 1998 |
| Received | Jul 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972657
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.