510(k) K954611 ยท LBI Unit, Neonatal Phototherapy
DRAGER PT4000 PHOTOTHERAPY SYSTEM
| Applicant | Drager, Inc., Chantilly VA, US |
| Decision | Substantially Equivalent, Dec 1, 1995 |
| Received | Oct 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954611
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2012 | Draeger Medical Systems, Inc. Drager PT 4000 Phototherapy System Terminated |
LBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.