510(k) K003561 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
| Applicant | Invacare Corp., Elyria OH, US |
| Decision | Substantially Equivalent, Apr 17, 2001 |
| Received | Nov 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003561
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.