510(k) K100011 ยท BZD Ventilator, Non-Continuous (Respirator)
FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
| Applicant | Fisher & Paykel Healthcare, Ltd., East Tamaki, Auckland, NZ |
| Decision | Substantially Equivalent, Oct 8, 2010 |
| Received | Jan 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100011
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.