510(k) K050918 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
KOO AMERICAS VALVE PEEP, MODEL KM-809
| Applicant | Koo Americas, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Jun 6, 2005 |
| Received | Apr 12, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050918
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.