510(k) K031935 ยท BZD Ventilator, Non-Continuous (Respirator)
TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530
| Applicant | Tiara Medical Systems, Inc., Lakewood OH, US |
| Decision | Substantially Equivalent, Mar 3, 2004 |
| Received | Jun 23, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031935
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.