510(k) K030797 ยท BZD Ventilator, Non-Continuous (Respirator)
S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM
| Applicant | Resmed Corp, Poway CA, US |
| Decision | Substantially Equivalent, Mar 10, 2004 |
| Received | Mar 13, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030797
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.