510(k) K992192 ยท BZD Ventilator, Non-Continuous (Respirator)
AIRPILOTMASK, MODEL TMS-900
| Applicant | Tiara Medical Systems, Inc., Lakewood OH, US |
| Decision | Substantially Equivalent, May 12, 2000 |
| Received | Jun 29, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992192
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.