510(k) K031176 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
| Applicant | Invacare Corp., Elyria OH, US |
| Decision | Substantially Equivalent, Mar 25, 2004 |
| Received | Apr 14, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031176
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.