510(k) K034053 ยท BZD Ventilator, Non-Continuous (Respirator)
TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040
| Applicant | Tiara Medical Systems, Inc., Lakewood OH, US |
| Decision | Substantially Equivalent, Jun 24, 2004 |
| Received | Dec 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K034053
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.