510(k) K964092 ยท BZD Ventilator, Non-Continuous (Respirator)
TMS COMFORT SERIES NASAL CPAP MASK
| Applicant | Tiara Medical Systems, Inc., Oak Forrest IL, US |
| Decision | Substantially Equivalent, Jul 31, 1997 |
| Received | Oct 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964092
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.