510(k) K040540 ยท CBK Ventilator, Continuous, Facility Use
MODIFICATION TO LTV 1000 VENTILATOR
| Applicant | Pulmonetic Systems, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 29, 2004 |
| Received | Mar 2, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040540
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2008 | Cardinal Health 203, Inc Viasys Healthcare, Pulmonetic Systems LTV 1000 Ventilator
The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightwei Terminated |
CBK | None listed |
| Aug 13, 2008 | Cardinal Health 203, Inc Viasys healthcare, Pulmonetic Systems LTV 950 Ventilator
The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight Terminated |
CBK | None listed |
| Aug 13, 2008 | Cardinal Health 203, Inc Viasys healthcare, Pulmonetic Systems LTV 900 Ventilator
The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight Terminated |
CBK | None listed |
| Aug 13, 2008 | Cardinal Health 203, Inc Viasys healthcare, Pulmonetic Systems LTV 800 Ventilator
The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight Terminated |
CBK | None listed |
| Aug 13, 2008 | Cardinal Health 203, Inc Replacement Kit, Power PCBA with DC power cord. REF 11590.
Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA. Terminated |
CBK | None listed |
| Aug 13, 2008 | Cardinal Health 203, Inc Replacement Kit, Power PCBA without Memory Board. REF 14157. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA. Terminated |
CBK | None listed |
| Aug 13, 2008 | Cardinal Health 203, Inc Replacement Kit, Power PCBA with Memory PCBA. REF 14425.
Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA. Terminated |
CBK | None listed |
| Aug 13, 2008 | Cardinal Health 203, Inc Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US.
Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA. Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.