510(k) K831163 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
LO-COMP RESERVOIR-RE-1000
| Applicant | Cygnus Research Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, May 3, 1983 |
| Received | Apr 11, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831163
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.