510(k) K120639 ยท CBK Ventilator, Continuous, Facility Use
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
| Applicant | Respironics, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Jul 10, 2012 |
| Received | Mar 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120639
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.