510(k) K053502 ยท CBK Ventilator, Continuous, Facility Use
NEWPORT E360 VENTILATOR
| Applicant | Newport Medical Instruments, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Jan 10, 2006 |
| Received | Dec 16, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2011 | Newport Medical Instruments Inc Newport e360 Ventilator, Model Number: e360
The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and moni Terminated |
CBK | None listed |
| May 19, 2010 | Newport Medical Instruments Inc Newport e360 Ventilator
The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, p Terminated |
CBK | None listed |
| Sep 4, 2009 | Newport Medical Instruments Inc Newport e360 Ventilator, Rx only.
The e360 Ventilator System is intended to provide continuous
(endotracheal or tracheostomy [ET] tube) or non-continuous
(mask) ventilatory support and monitoring fo Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.