510(k) K043382 ยท BZD Ventilator, Non-Continuous (Respirator)
TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840
| Applicant | Tiara Medical Systems, Inc., Lakewood OH, US |
| Decision | Substantially Equivalent, Jan 19, 2005 |
| Received | Dec 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043382
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.