510(k) K984535 ยท CBK Ventilator, Continuous, Facility Use
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
| Applicant | Puritan Bennett Corp., Carlsbad CA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Dec 28, 1998 |
| Received | Dec 21, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K984535
| 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.