SERVO VENTILATOR 300
FDA 510(k) clearance K902859 · decided 1991-04-26
Clearance details
- K-number
- K902859
- Device name
- SERVO VENTILATOR 300
- Applicant
- Siemens Life Support Systems
- Decision
- Substantially Equivalent
- Date received
- 1990-06-29
- Decision date
- 1991-04-26
- Days to decision
- 301 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Schaumburg, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB, recall (Z-0588-2010) | MAQUET Inc. | 2010-01-05 |
| Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is i recall (Z-1252-2009) | MAQUET Inc. | 2009-05-12 |
| Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action ta recall (Z-0571-05) | Maquet Inc | 2005-03-08 |