510(k) K123149 ยท CBK Ventilator, Continuous, Facility Use
SERVO-I VENTILATOR SYSTEM
| Applicant | Maquet Critical Care AB, Wayne NJ, US |
| Decision | Substantially Equivalent, Jun 20, 2014 |
| Received | Oct 5, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K123149
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2020 | Getinge Group Logistics America, LLC Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in differen Open, Classified |
CBK | None listed |
| Feb 27, 2015 | Maquet Cardiovascular Us Sales, Llc Servo-I ventilator system CO2 analyzer. Part number 65 23 588. Terminated |
CBN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.