510(k) K012207 ยท BZD Ventilator, Non-Continuous (Respirator)
ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530
| Applicant | Tiara Medical Systems, Inc., Lakewood OH, US |
| Decision | Substantially Equivalent, Jul 23, 2001 |
| Received | Jul 16, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012207
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.