510(k) K192604 ยท CBK Ventilator, Continuous, Facility Use
Servo-air 4.0 Ventilator System
| Applicant | Maquet Critica Care AB, Solna, SE |
| Decision | Substantially Equivalent, Jun 18, 2020 |
| Received | Sep 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2022 | Getinge Usa Sales Inc 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 688199 Open, Classified |
CBK | None listed |
| Jul 20, 2022 | Getinge Usa Sales Inc 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 688200 Open, Classified |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.