510(k) K051583 ยท BZD Ventilator, Non-Continuous (Respirator)
TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050
| Applicant | Tiara Medical Systems, Inc., Lakewood OH, US |
| Decision | Substantially Equivalent, Nov 4, 2005 |
| Received | Jun 15, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051583
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.