510(k) K981072 ยท CBK Ventilator, Continuous, Facility Use
ESPRIT VENTILATOR
| Applicant | Respironics, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Nov 12, 1998 |
| Received | Mar 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981072
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2014 | Respironics California Inc Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator
The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Inten Terminated |
CBK | None listed |
| Oct 21, 2014 | Respironics California Inc Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits
Microprocessor-controlled, electrically powered mechanical ventilators intended f Terminated |
CBK | None listed |
| Aug 26, 2013 | Respironics California Inc Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000 Terminated |
CBK | None listed |
| Aug 11, 2009 | Respironics California Inc Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456. Terminated |
CBK | None listed |
| Sep 17, 2008 | Respironics California Inc Esprit Ventilator, Model V1000 manufactured with Power Supply PN 1015852
The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. Terminated |
CBK | None listed |
| Sep 17, 2008 | Respironics California Inc Esprit Power Supply Snubber Board Assembly FRU, PN 1036236
The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. Terminated |
CBK | None listed |
| Sep 17, 2008 | Respironics California Inc Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246
The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. Terminated |
CBK | None listed |
| Oct 19, 2006 | Respironics California Inc Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics 1018246 Terminated |
CBK | None listed |
| Jul 28, 2004 | Respironics California Inc Esprit Ventilator Terminated |
CBK | None listed |
| Jul 20, 2004 | Respironics California Inc Espirit Ventilator, Model V1000
Continuous Ventilator with Respiratory Mechanics Terminated |
CBK | None listed |
| Jul 1, 2003 | Respironics California Inc ESPRIT VENTILATOR, Model V1000 Terminated |
CPK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.