510(k) K950397 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
SYSTEM 22 VALVE
| Applicant | Turnkey Intergration USA, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 14, 1995 |
| Received | Feb 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950397
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.