510(k) K083688 ยท CBK Ventilator, Continuous, Facility Use
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
| Applicant | Pulmonetic Systems, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 18, 2009 |
| Received | Dec 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083688
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2010 | CareFusion 203, Inc. Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg.
These circuits are intended for use with the MR Conditional LTV 1200 System with the ventilator utilizing an external exhalat Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.