510(k) K101130 ยท MNS Ventilator, Continuous, Non-Life-Supporting
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Sep 2, 2010 |
| Received | Apr 22, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101130
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.