510(k) K053388 ยท CBK Ventilator, Continuous, Facility Use
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
| Applicant | Puritan Bennett Corp., Pleasanton CA, US |
| Decision | Substantially Equivalent, Apr 4, 2006 |
| Received | Dec 5, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053388
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2014 | Covidien Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG.
The intended use of the product is to provide mechanical ventilation to patients. Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.