510(k) K970516 ยท BZD Ventilator, Non-Continuous (Respirator)
SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM
| Applicant | Resmed, Ltd., Sydney, New South Wales, AU |
| Decision | Substantially Equivalent, May 9, 1997 |
| Received | Feb 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970516
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.