510(k) K010608 ยท CBK Ventilator, Continuous, Facility Use
MODIFICATION TO LAP TOP VENTILATOR (LTV)
| Applicant | Pulmonetic Systems, Inc., Colton CA, US |
| Decision | Substantially Equivalent, Mar 20, 2001 |
| Received | Mar 1, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010608
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2005 | Pulmonetic Systems, Inc. Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who req Terminated |
CBK | None listed |
| Nov 23, 2005 | Pulmonetic Systems, Inc. Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who requ Terminated |
CBK | None listed |
| Nov 23, 2005 | Pulmonetic Systems, Inc. Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who requ Terminated |
CBK | None listed |
| 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.