Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1— 510(k) K201874
Substantially EquivalentMaquet Critical Care AB
FDA 510(k) clearance K201874 for Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1, Substantially Equivalent on 2021-04-20. Applicant: Maquet Critical Care AB. Device class: 2.
Clearance details
- Applicant
- Maquet Critical Care AB
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Solna, SE
Recent devices under product code CBK
view allMore clearances from Maquet Critical Care AB
view allAdverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K201874
K-number listed on FDA's recall record- Z-2963-2026 — GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
- Z-2013-2025 — Servo-u Ventilator System. Model Number: 6688600.
- Z-2014-2025 — Servo-n Ventilator System. Model Number: 6694800.
- Z-2015-2025 — Servo-u MR Ventilator System. Model Number: 6888800.
- Z-1560-2022 — Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201874.
Data sourced from openFDA. This site is unofficial and independent of the FDA.