510(k) K102224 ยท BZD Ventilator, Non-Continuous (Respirator)
PIXI PEDIATRIC MASK
| Applicant | Resmed, Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 10, 2010 |
| Received | Aug 6, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102224
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.