510(k) K032226 ยท CBK Ventilator, Continuous, Facility Use
LTV-1000 VENTILATOR
| Applicant | Pulmonetic Systems, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 16, 2003 |
| Received | Jul 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032226
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2004 | Cardinal Health 203, Inc The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for u Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.