510(k) K952475 ยท BZD Ventilator, Non-Continuous (Respirator)
SULLIVAN NOSE & MOUTH MASK SYSTEM
| Applicant | Rescare , Ltd., North Ryde, New South Wales, AU |
| Decision | Substantially Equivalent, May 28, 1996 |
| Received | May 30, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952475
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.