Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
FDA 510(k) clearance K201874 · decided 2021-04-20
Clearance details
- K-number
- K201874
- Device name
- Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
- Applicant
- Maquet Critical Care AB
- Decision
- Substantially Equivalent
- Date received
- 2020-07-07
- Decision date
- 2021-04-20
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Solna, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, f recall (Z-2963-2026) | Maquet Critical Care AB | 2026-08-14 |
| Servo-u Ventilator System. Model Number: 6688600. recall (Z-2013-2025) | Maquet Critical Care AB | 2025-06-27 |
| Servo-n Ventilator System. Model Number: 6694800. recall (Z-2014-2025) | Maquet Critical Care AB | 2025-06-27 |
| Servo-u MR Ventilator System. Model Number: 6888800. recall (Z-2015-2025) | Maquet Critical Care AB | 2025-06-27 |