510(k) K974176 ยท CBK Ventilator, Continuous, Facility Use
BABYLOG 8000 PLUS
| Applicant | Drager, Inc., Telford PA, US |
| Decision | Substantially Equivalent, Jun 17, 1998 |
| Received | Nov 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974176
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2006 | Draeger Medical, Inc. Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.