510(k) K850069 ยท FMT Warmer, Infant Radiant
BORNING NEONATAL RESUSCITATOIN CENTER
| Applicant | Borning Corp., Spokane WA, US |
| Decision | Substantially Equivalent, May 30, 1985 |
| Received | Jan 3, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850069
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2009 | Draeger Medical Systems, Inc. Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200. Terminated |
FMT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.