510(k) K801619 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
MIST2GEN TEMPTROL 10
| Applicant | Mistogen Equipment Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 4, 1980 |
| Received | Jul 15, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801619
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.