510(k) K894734 ยท KFZ Humidifier, Non-Direct Patient Interface (Home-Use)
RHINOTHERM ULTRA 2
| Applicant | Twinmed Products, Inc., Santa Monica CA, US |
| Decision | Substantially Equivalent, Feb 16, 1990 |
| Received | Jul 24, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894734
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.