510(k) K970839 ยท CBK Ventilator, Continuous, Facility Use
SERVO VENTILATOR 300A
| Applicant | Siemens Elema AB, S-17195 Solna, SE |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Oct 14, 1997 |
| Received | Mar 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970839
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2010 | MAQUET Inc. Maquet Servo Ventilator 300/300A (SV300)
Siemens - Elema AB, Terminated |
CBK | None listed |
| May 12, 2009 | MAQUET Inc. Servo Ventilator 300 (Model SV300) and
Servo Ventilator 300 (Model SV300A).
The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. Terminated |
CBK | None listed |
| Feb 3, 2009 | MAQUET Inc. SERVO Ventilator 300A (SV300A);
Maquet Critical Care Ab, Solna, Sweden.
The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit Terminated |
CBK | None listed |
| Mar 8, 2005 | Maquet Inc Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, S Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.