510(k) K072885 ยท CBK Ventilator, Continuous, Facility Use
CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
| Applicant | Draeger Medical AG & Co. KG, Telford PA, US |
| Decision | Substantially Equivalent, Apr 7, 2008 |
| Received | Oct 9, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072885
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2023 | Draeger Medical, Inc. Carina Sub-Acute Care Ventilator Open, Classified |
CBK | None listed |
| Apr 26, 2018 | Draeger Medical, Inc. Carina Ventilator, ventilator. Catalog no. 5704110.
Long-term ventilator for treatment in hospitals by a qualified medical personnel. Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.