Company ยท US
Pulmonetic Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2009. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 18, 2009 | K083688 | PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR Pulmonetic Systems, Inc. | CBK |
| Aug 1, 2007 | K070594 | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 Pulmonetic Systems, Inc. | CBK |
| May 25, 2006 | K060647 | LTV 1200 VENTILATOR Pulmonetic Systems, Inc. | CBK |
| May 4, 2006 | K060549 | AUTOMOBILE LIGHTER POWER CORD Pulmonetic Systems, Inc. | CBK |
| Jul 29, 2005 | K051767 | LTV 1000 VENTILATOR Pulmonetic Systems, Inc. | CBK |
| Jun 3, 2004 | K040790 | MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS Pulmonetic Systems, Inc. | CBK |
| Apr 29, 2004 | K040540 | MODIFICATION TO LTV 1000 VENTILATOR Pulmonetic Systems, Inc. | CBK |
| Oct 16, 2003 | K032226 | LTV-1000 VENTILATOR Pulmonetic Systems, Inc. | CBK |
| Mar 20, 2001 | K010608 | MODIFICATION TO LAP TOP VENTILATOR (LTV) Pulmonetic Systems, Inc. | CBK |
| Oct 11, 2000 | K002881 | VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 Pulmonetic Systems, Inc. | CBK |
| Apr 12, 1999 | K984056 | LTV 1000 Pulmonetic Systems, Inc. | CBK |
| Oct 30, 1998 | K981371 | LTV 1000 VENTILATOR Pulmonetic Systems, Inc. | CBK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K002881 K010608 +2 |
| 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 | K002881 K010608 +2 |
| 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 | K002881 K010608 +2 |
| Dec 8, 2004 | Pulmonetic Systems, Inc. Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 1000 with either part # 10134 or Terminated |
NOU | None listed |
| Dec 8, 2004 | Pulmonetic Systems, Inc. Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 900 with either part # 10134 or 1 Terminated |
NOU | None listed |
| Dec 8, 2004 | Pulmonetic Systems, Inc. Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 950 with either part # 10134 or 1 Terminated |
NOU | None listed |
| Dec 8, 2004 | Pulmonetic Systems, Inc. Universal Cable Adaptor (Part #17765-001 and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV series Ventilator, Model 800 with either part # 10134 or Terminated |
NOU | None listed |