510(k) K010317 ยท CBK Ventilator, Continuous, Facility Use
AV 800 VENTILATOR
| Applicant | Penlon , Ltd., Oxfordshire, GB |
| Decision | Substantially Equivalent, Jul 23, 2001 |
| Received | Feb 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010317
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.