510(k) K091066 ยท BZD Ventilator, Non-Continuous (Respirator)
COMFORT TWIN NASAL MASK
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Sep 3, 2009 |
| Received | Apr 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091066
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.