510(k) K103625 ยท CBK Ventilator, Continuous, Facility Use
OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
| Applicant | Draeger Medical Systems, Inc., Telford PA, US |
| Decision | Substantially Equivalent, Oct 6, 2011 |
| Received | Dec 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103625
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2023 | Draeger Medical, Inc. Oxylog 3000 Plus emergency and transport ventilator Open, Classified |
CBK | None listed |
| Feb 3, 2016 | Draeger Medical, Inc. Emergency Transport Ventilator
Oxylog 2000 Plus Ventilator
Catalog Number: 5705080.
Volume controlled emergency and transport ventilator with pressure support. Terminated |
CBK | None listed |
| Feb 3, 2016 | Draeger Medical, Inc. Emergency Transport Ventilator
Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator
Catalog Numbers: 2M86300/2M86965 and 5704813/5704831.
Volume controlled and pressure-controlled emergency and tra Terminated |
CBK | None listed |
| Apr 10, 2014 | Draeger Medical Systems, Inc. Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833 Terminated |
BTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.