510(k) K010925 ยท CBK Ventilator, Continuous, Facility Use
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
| Applicant | Siemens Elema AB, Iselin NJ, US |
| Decision | Substantially Equivalent, Dec 18, 2001 |
| Received | Mar 27, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K010925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2007 | MAQUET Inc. Ventilator System SERVO-i V3.1 PC1777
Maquet Critical Care Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.