510(k) K854363 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
SARATOGA SCT HEATED HUMIDIFICATION SYSTEM
| Applicant | Saratoga Medical Instrumentation, Inc., Hadley NY, US |
| Decision | Substantially Equivalent, Dec 31, 1985 |
| Received | Oct 29, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854363
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.