510(k) K031064 ยท BZD Ventilator, Non-Continuous (Respirator)
INVACARE POLARIS EX CPAP, MODEL ISP3000
| Applicant | Invacare Corp., Elyria OH, US |
| Decision | Substantially Equivalent, Mar 12, 2004 |
| Received | Apr 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031064
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.