510(k) K083122 ยท CBK Ventilator, Continuous, Facility Use
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
| Applicant | Fisher & Paykel Healthcare, Ltd., East Tamaki, NZ |
| Decision | Substantially Equivalent, Mar 4, 2009 |
| Received | Oct 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083122
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.