510(k) K001318 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
CPAP SYSTEM, MODEL 102001
| Applicant | Sims Portex, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Jul 20, 2000 |
| Received | Apr 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001318
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.