Servo-air 4.0 Ventilator System— 510(k) K192604
Substantially EquivalentMaquet Critica Care AB
FDA 510(k) clearance K192604 for Servo-air 4.0 Ventilator System, Substantially Equivalent on 2020-06-18. Applicant: Maquet Critica Care AB. Device class: 2.
Clearance details
- Applicant
- Maquet Critica 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 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 K192604
K-number listed on FDA's recall record- Z-1568-2022 — Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
- 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 K192604.
Data sourced from openFDA. This site is unofficial and independent of the FDA.