510(k) K970448 ยท MSH Respirator, Surgical
PCM 2000; ISOLAIR APR MODEL 2735
| Applicant | Tecnol Medical Products, Inc., Fort Worth TX, US |
| Decision | Substantially Equivalent, Apr 30, 1997 |
| Received | Feb 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970448
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.