510(k) K093633 · CBK Ventilator, Continuous, Facility Use
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
| Applicant | Draegerwerk AG & CO Kgaa, Lübeck, DE |
| Decision | Substantially Equivalent, Mar 30, 2010 |
| Received | Nov 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093633
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2022 | Draeger Medical, Inc. Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients
Catalog Number: 8416400 Terminated |
CBK | None listed |
| Sep 10, 2021 | Draeger Medical, Inc. Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients.
Catalog Number: 8416400 Open, Classified |
CBK | None listed |
| Feb 25, 2016 | Draeger Medical, Inc. Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator.
Ventilation. Terminated |
CBK | None listed |
| Dec 23, 2015 | Draeger Medical, Inc. Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator.
Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients. Terminated |
CBK | None listed |
| Aug 14, 2015 | Draeger Medical, Inc. PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients. Terminated |
CBK | None listed |
| Mar 28, 2014 | Draeger Medical Systems, Inc. Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.