510(k) K070594 ยท CBK Ventilator, Continuous, Facility Use
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
| Applicant | Pulmonetic Systems, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 1, 2007 |
| Received | Mar 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070594
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2014 | CareFusion 203, Inc. CareFusion EnVe and ReVel Ventilators.
The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It i Terminated |
CBK | None listed |
| Jul 16, 2012 | CareFusion 203, Inc. CareFusion EnVe Ventilator
Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and tran Terminated |
CBK | None listed |
| Oct 26, 2011 | CareFusion 203, Inc. CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range Terminated |
CBK | None listed |
| Feb 25, 2010 | CareFusion 203, Inc. Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341.
Intended to provide continuous or intermittent ventilatory support for the care of indivi Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.