510(k) K013642 ยท CBK Ventilator, Continuous, Facility Use
AVEA
| Applicant | Bird Products Corp., Palm Spring CA, US |
| Decision | Substantially Equivalent, May 22, 2002 |
| Received | Nov 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013642
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14)
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of Terminated |
CBK | None listed |
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion AVEA Standard ventilator, 17311-xx (xx = 0 - 14)
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen Terminated |
CBK | None listed |
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14)
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined perc Terminated |
CBK | None listed |
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14)
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined perc Terminated |
CBK | None listed |
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14)
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage Terminated |
CBK | None listed |
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14)
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predeter Terminated |
CBK | None listed |
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion TCA Board, 16542A
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Terminated |
CBK | None listed |
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion Gas Delivery Engine (GDE)-1st Generation, 16222-001-99
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of o Terminated |
CBK | None listed |
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion Gas Delivery Engine (GDE), 16650A
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathin Terminated |
CBK | None listed |
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion Gas Delivery Engine (GDE)-refurbished, R16650A
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in Terminated |
CBK | None listed |
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion AVEA GDE/UIM upgrade kit, 12283-PMN
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breath Terminated |
CBK | None listed |
| Jun 13, 2016 | Carefusion 211 Inc dba Carefusion AVEA GDE upgrade kit, 12284-PMN
A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing Terminated |
CBK | None listed |
| Sep 27, 2013 | Carefusion 211 Inc dba Carefusion Product Name: AVEA Ventilator.
All Models.
The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device.
A continuous ventilator (r Terminated |
CBK | None listed |
| Jan 11, 2012 | Carefusion 211 Inc AVEA Ventilator (Catalog Code 17310, 17311, 17312).
The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neon Terminated |
CBK | None listed |
| May 14, 2008 | Viasys Respiratory Care, Inc.dba Bird Products VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version) Terminated |
CBK | None listed |
| May 14, 2008 | Viasys Respiratory Care, Inc.dba Bird Products VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version) Terminated |
CBK | None listed |
| May 14, 2008 | Viasys Respiratory Care, Inc.dba Bird Products VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version) Terminated |
CBK | None listed |
| May 14, 2008 | Viasys Respiratory Care, Inc.dba Bird Products VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version) Terminated |
CBK | None listed |
| May 14, 2008 | Viasys Respiratory Care, Inc.dba Bird Products VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version) Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.